Amyotrophic Lateral Sclerosis
Conditions
Keywords
Amyotrophic Lateral Sclerosis, Biotelemetry
Brief summary
Study 201283 is an exploratory, non-controlled, non-drug study in Amyotrophic Lateral Sclerosis (ALS) subjects. This study is being conducted as the first step for developing new meaningful measure(s) which might prove to be more effective than existing measures for monitoring clinical function and disease course in ALS. The objective of this study is to test novel measures of movement/physical activity, heart rate and speech and explore how they measure disease progression by evaluating their relationship to gold standard measures of function. This study will be conducted in two phases. A variable length Pilot Phase to test biotelemetry instruments and algorithms reliability and ease of use/acceptance. Approximately 5 subjects will have at least 1 clinic visit to perform a series of set reference tasks while wearing the accelerometer and electrode. Subjects will also continuously wear the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (i.e., home monitoring). Subjects in the Pilot Phase will continue in the study and participate in the Core Study Phase. A 48 week Core Study Phase will be conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. During this phase, a maximum of 25 subjects will be enrolled. Subjects will attend 5 clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, every month subjects will attach the accelerometer and electrode and wear it for approximately 3 days in their home. A telephone contact with the subject will be made by the site at the end of each 3-day home monitoring period. All third party trademark rights are the rights of their respective owners.
Interventions
DEVICEFaros Sensor (FS) and LifeInsight Hub
Each subject will be issued one FS and a MAT LifeInsight Hub for use during the study. At each clinic visit in the Pilot and Core Study Phases, the Faros sensor will be placed on the subject just prior to the defined reference tasks and will be worn on the subject's sternum during completion of the tasks. The morning after the clinic visit, the subject will re-attach the sensor and wear it for approximately 3 days. In between visits during the Core Study Phase the subject will wear the FS every month for approximately 3 days to enable data collection on a monthly basis over the 48 week study period. Movement/physical activity data will be collected by the FS throughout the study.
DEVICEFast Fix electrode patch
The Fast Fix electrode patch will be worn with the FS on the subject's sternum according to the same schedule as the FS. The Fast Fix electrode patch will be replaced by the subject on a daily basis during the 3 day monitoring period. Subjects will be provided instructions on how to operate and wear the Fast Fix electrode patch.
PROCEDUREQuantitative Measure of Speech (Core Phase Only)
Subjects will follow simple prompts on a computer screen instructing them to say a series of vowels, words, and paragraphs which will be recorded using a high definition digital microphone and stored securely on a laptop. The speech waveform data will be sent via secure method to GSK/MAT for processing.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Between 18 and 80 years of age, inclusive, at the time of signing the informed consent. * Diagnosed with ALS by a neurologist with expertise in ALS. For subjects with bulbar onset there must be objective limb involvement of at least one limb. * Diagnosed with ALS within 18 months of symptom onset. * Subjects must be ambulatory (i.e., must not be confined to a wheelchair). * Male and female subjects. * Capable of giving signed (or verbal consent or assent where applicable) informed consent as described in Protocol which includes compliance with the requirements and restrictions listed in the consent form and in protocol. * Capable and willing to comply with the requirements of the protocol (either by themselves or with assistance).
Exclusion criteria
* Neurological (other than the subject's ALS) or non-neurological co-morbidities (e.g. joint disease, respiratory disease) which limit mobility. * Clinically significant cognitive impairment in the opinion of the investigator. * Regionally restricted forms of ALS, or other atypical variants: Isolated corticobulbar pattern of ALS with normal ambulation; Flail arm syndrome; Primary lateral sclerosis; Signs of chronic partial denervation restricted to a single limb; ALS parkinsonism dementia complex * Subjects requiring mechanical ventilation (non-invasive ventilation for sleep apnoea is allowed). * Historical or current evidence of clinically significant uncontrolled disease which, in the opinion of the investigator, would put the safety of the subject at risk through participation or impact the study assessments or endpoints. * Presence of an active implantable cardiac medical device (e.g., pacemaker or implantable cardioverter-defibrillator) or at a high risk for needing external defibrillation. * History of skin hypersensitivity to adhesives. * Current participation in a clinical trial which in the opinion of the investigator and GSK medical monitor might impact the objectives of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Day Time Wear Time of the Device | Up to Week 48 | Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of day time wear time was calculated by adding the durations of the time spent \[Active + lying + sedentary not lying\] in the day time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).NA indicates that data could not be calculated as participant number was \<=1. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Average Time Spent Active | Up to Week 48 | Number of minutes spent active per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles) |
| Average Time Spent 'Sedentary Not Lying' | Up to Week 48 | Number of minutes spent 'sedentary not lying' per day and night for 24-hour recording period; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Average Time Spent Lying | Up to Week 48 | Number of minutes spent lying per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Average Time Spent Sedentary. | Up to Week 48 | Number of minutes spent sedentary \[time spent lying + time spent sedentary not lying\] per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Time Spent With Sensor Off | Up to Week 48 | Sensor off time includes the time that the sensor was either switched off or the participant was not wearing it (or both). This outcome measure was planned but not performed. |
| Total Activity Count | Up to Week 48 | Total activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Maximum Activity Count in a 24 Hour Period | Up to Week 48 | Maximum activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles) |
| Mean Maximum Activity Count in a 24 Hour Period | Up to Week 48 | Mean maximum activity count of day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles) |
| Number of Continuous Active Periods | Up to Week 48 | Active periods were catagorized as \>1minute to \<=2minutes, \>2 minutes to \<=5minutes, \>5 minutes to \<=15 minutes, \>15 minutes to \<=30 minutes, \>30 minutes. Total number of 'active periods were calculated as 1minute\<x\<2minutes + 'number of active periods 2minutes\<x\<5minutes + 'number of active periods 5minutes\<x\<15minutes + 'number of active periods 15minutes\<x\<30minutes + 'number of active periods \>30minutes. |
| Percent of Time Lying Down at Night | Up to Week 48 | Percent time spent lying per day and night over the 24-hour recording periods; averaged for each timepoint |
| Number of Night Time Movement Episodes Per Hour | Up to Week 48 | Average number of night movement episodes per hour for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Percent Time Night-time Rest Efficiency | Up to Week 48 | Average night-time rest efficiency for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles) |
| Rest Fragmentation Index | Up to Week 48 | Rest Fragmentation Index was computed as movement time (%) divided by number of movement episodes for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Average Duration of Night Time Movement Episodes | Up to Week 48 | Average duration of movement episodes for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Relationship Between Average Number Night Time Movements/Hour Versus Total ALSFRS-R | Up to Week 48 | Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented |
| Relationship Between Average Duration Movement Episodes at Night Versus Total ALSFRS-R | Up to Week 48 | Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented |
| Relationship Between Average Percent Time Night Time Rest Efficiency Versus Total ALSFRS-R | Up to Week 48 | Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented |
| Relationship Between Average Night Time Rest Fragmentation Index Versus Total ALSFRS-R | Up to Week 48 | Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented |
| Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) | Up to Week 48 | Mean Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Variance of HRV While Lying (LF/HF) | Up to Week 48 | Variance of Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Mean HRV While Sedentary Not Lying (LF/HF) | Up to Week 48 | Mean Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Variance of HRV While Sedentary Not Lying (LF/HF) | Up to Week 48 | Variance of Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Mean HRV While Active (LF/HF) | Up to Week 48 | Mean Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data is not available. Standard deviation could not be calculated when number of participants was \<=1 |
| Variance of HRV While Active (LF/HF) | Up to Week 48 | Variance of Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1 |
| Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) | Up to Week 48 | The effect of being upright on mean HRV was calculated as \[mean HRV while sedentary not lying minus mean HRV while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Effect of Being Upright on HRV Variance (LF/HF Analysis) | Up to Week 48 | The effect of being upright on HRV variance was calculated as \[HRV variance while sedentary not lying minus HRV variance while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Effect of Activity on Mean HRV (LF/HF) | Up to Week 48 | The effect of activity on mean HRV was calculated as \[mean HRV while sedentary not lying minus mean HRV while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1. |
| Effect of Activity on HRV Variance (LF/HF Analysis) | Up to Week 48 | The effect of activity on HRV variance was calculated as \[HRV variance while sedentary not lying minus HRV variance while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1. |
| Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) | Up to Week 48 | Mean HRV over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis | Up to Week 48 | HRV variance over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R | Up to Week 48 | Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that sample size was insufficient to calculate correlation coefficient |
| Measurement of Speech Quality | Up to Week 48 | Speech quality was assessed by Central Tendency of Fundamental Frequency (CTF) F0, jitter, and shimmer for 'short ah' and 'long ah' tests. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Duration of Maximum Gap Between Words | Up to Week 48 | Duration of maximum gap between words during running speech to planned to analyze quality of speech however; was not performed. |
| Speaking Rate | Up to Week 48 | Speaking rate was analyzed during running speech. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Average Phoneme Rate | Up to Week 48 | Phoneme rate was analyzed for the single word doily. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Maximum Phonation Time | Seconds | Maximum phonation time for the single word doily test was analyzed for quality of speech testing. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Percentage Pause Time | Up to Week 48 | Percentage pause time for running speech was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Relationship Between Absolute Values of Speech Endpoints and Absolute Value of ALSFRS-R | Up to Week 48 | Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Repeated Measures Correlation Coefficient has been presented in the table below |
| Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC | Up to Week 48 | Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Between Subject Correlation Coefficient has been presented in the table below |
| Number of Participants Reporting Sensor Comfort | Up to Week 48 | Participant's feedback on whether the sensor was comfortable to wear was categorized as yes and no. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Number of Participants Reporting Impact on Sleep | Up to Week 48 | Participant feedback on how much the sensor impacted their sleep was categorized as not at all, moderately and minimally. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Duration of Night Time Wear Time of the Device | Up to Week 48 | Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of night time wear time was the calculated as the total of the times spent \[Active + day time lying + day time sedentary not lying\] for the night time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1. |
| Number of Participants With Corresponding Activity Level Required to Complete Their Job | Up to Week 48 | The activity level required by the participant to complete their job was recorded, and was categorized as Not working, Physical activity required, and Sedentary. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Up to Week 48 | Average activity level during the time of wearing the sensor was reported by the participants, and was categorized as very low level activity, low level activity, moderate level activity and high level activity. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Number of Participants Whose Sensor Fell Off | Up to Week 48 | The participants reported whether the sensor fell off. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Number of Participants With Adverse Events Secondary to the Devices Used or Due to Study Procedures | Up to Week 48 | Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. |
| Type of Adverse Events Secondary to the Devices Used or Due to Study Procedures | Up to Week 48 | Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Number of AEs, SAEs and Adverse events leading to discontinuation (AELDs)from the study is presented |
| Number of Participants With Ease of Setting up and Attaching the Sensor | Up to Week 48 | The participants were required to give feedback on how easy was it to set up and/ or attach the sensor and it was categorized as easy, neutral and difficult. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
Countries
United Kingdom
Participant flow
Recruitment details
This is an exploratory, non-controlled, non-drug study in participants with amyotrophic lateral sclerosis (ALS). The study enrolled participants using two sites based in the United Kingdom
Pre-assignment details
Of total 25 screened participants, 5 participants were included in pilot phase of which 2 completed and entered core study phase with other 23 participants.
Participants by arm
| Arm | Count |
|---|---|
| Mega Faros Device + Fast Fix In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Mega Faros Device + Fast Fix |
|---|---|
| Age, Continuous | 53.1 Years STANDARD_DEVIATION 9.93 |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 1 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 1 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 23 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 6 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Duration of Day Time Wear Time of the Device
Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of day time wear time was calculated by adding the durations of the time spent \[Active + lying + sedentary not lying\] in the day time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).NA indicates that data could not be calculated as participant number was \<=1.
Time frame: Up to Week 48
Population: Full Analysis Set included all participants with at least one post Baseline measure for the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) and at least one physical activity/movement measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week 0, Day 5, n=2 | 342.830 Minutes | Standard Deviation 240.4163 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week 0, Day 1, n=24 | 718.536 Minutes | Standard Deviation 190.4933 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week 0, Day 2, n=24 | 730.882 Minutes | Standard Deviation 216.3616 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week 0, Day 3, n=23 | 653.980 Minutes | Standard Deviation 241.0427 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week 0, Day 4, n=12 | 207.263 Minutes | Standard Deviation 275.7507 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week4, Day 1, n=22 | 762.680 Minutes | Standard Deviation 228.5267 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week4, Day 2, n=22 | 778.636 Minutes | Standard Deviation 169.6978 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week4, Day 3, n=21 | 605.334 Minutes | Standard Deviation 319.5373 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week4, Day 4, n=9 | 207.092 Minutes | Standard Deviation 293.8405 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week4, Day 5, n=5 | 137.600 Minutes | Standard Deviation 300.5371 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week4, Day 6, n=1 | 657.500 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week12,Day 5, n=1 | 858.660 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week4, Day 7, n=1 | 820.660 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week4, Day 8, n=1 | 34.000 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week8, Day 1, n=19 | 647.735 Minutes | Standard Deviation 291.5468 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week8, Day 2, n=17 | 744.028 Minutes | Standard Deviation 158.389 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week8, Day 3, n=17 | 581.939 Minutes | Standard Deviation 297.5053 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week8, Day 4, n=8 | 94.709 Minutes | Standard Deviation 126.7088 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week12,Day 1, n=16 | 552.668 Minutes | Standard Deviation 315.5227 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week12,Day 2, n=16 | 801.697 Minutes | Standard Deviation 170.86 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week12,Day 3, n=15 | 563.311 Minutes | Standard Deviation 298.3566 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week12,Day 4, n=7 | 425.336 Minutes | Standard Deviation 266.842 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week16,Day 1, n=13 | 759.399 Minutes | Standard Deviation 129.2502 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week16,Day 2, n=13 | 812.345 Minutes | Standard Deviation 200.5683 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week16,Day 3, n=12 | 631.484 Minutes | Standard Deviation 296.305 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week16,Day 4, n=6 | 254.500 Minutes | Standard Deviation 336.6649 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week20,Day 1, n=14 | 774.049 Minutes | Standard Deviation 240.7234 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week20,Day 2, n=13 | 648.268 Minutes | Standard Deviation 291.9654 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week20,Day 3, n=12 | 615.277 Minutes | Standard Deviation 239.5376 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week20,Day 4, n=4 | 172.793 Minutes | Standard Deviation 345.3584 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week24,Day 1, n=14 | 505.976 Minutes | Standard Deviation 296.3016 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week24,Day 2, n=12 | 617.599 Minutes | Standard Deviation 299.5749 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week24,Day 3, n=11 | 481.698 Minutes | Standard Deviation 333.5209 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week24,Day 4, n=8 | 306.500 Minutes | Standard Deviation 303.9026 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week24,Day 5, n=2 | 287.000 Minutes | Standard Deviation 184.7953 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week28,Day 1, n=10 | 690.898 Minutes | Standard Deviation 178.9577 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week28,Day 2, n=10 | 722.551 Minutes | Standard Deviation 248.5576 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week28,Day 3, n=9 | 588.464 Minutes | Standard Deviation 359.3972 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week28,Day 4, n=6 | 357.220 Minutes | Standard Deviation 363.205 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week32,Day 1, n=12 | 575.303 Minutes | Standard Deviation 322.1123 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week32,Day 2, n=10 | 592.866 Minutes | Standard Deviation 345.4597 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week32,Day 3, n=9 | 599.778 Minutes | Standard Deviation 351.8631 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week32,Day 4, n=1 | 32.000 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week36,Day 1, n=12 | 510.209 Minutes | Standard Deviation 381.706 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week36,Day 2, n=9 | 507.872 Minutes | Standard Deviation 397.7501 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week36,Day 3, n=6 | 465.583 Minutes | Standard Deviation 340.8965 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week36,Day 4, n=4 | 387.750 Minutes | Standard Deviation 424.1863 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week36,Day 5, n=2 | 516.250 Minutes | Standard Deviation 454.3161 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week36,Day 6, n=1 | 171.840 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week40,Day 1, n=12 | 722.708 Minutes | Standard Deviation 239.1189 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week40,Day 2, n=12 | 618.555 Minutes | Standard Deviation 326.7927 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week40,Day 3, n=11 | 601.665 Minutes | Standard Deviation 312.9329 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week40,Day 4, n=7 | 290.857 Minutes | Standard Deviation 404.5156 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week40,Day 5, n=1 | 823.500 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week40,Day 6, n=1 | 444.830 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week44,Day 1, n=12 | 746.278 Minutes | Standard Deviation 258.7132 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week44,Day 2, n=11 | 646.452 Minutes | Standard Deviation 295.5684 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week44,Day 3, n=10 | 476.783 Minutes | Standard Deviation 355.1196 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week44,Day 4, n=4 | 178.460 Minutes | Standard Deviation 308.3123 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week44,Day 5, n=1 | 146.660 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week48,Day 1, n=13 | 779.438 Minutes | Standard Deviation 120.7527 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week48,Day 2, n=13 | 692.474 Minutes | Standard Deviation 251.7305 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week48,Day 3, n=10 | 622.015 Minutes | Standard Deviation 243.504 |
| Mega Faros Device + Fast Fix | Duration of Day Time Wear Time of the Device | Week48,Day 4, n=5 | 630.000 Minutes | Standard Deviation 380.2256 |
Other Pre-specified
Average Duration of Night Time Movement Episodes
Average duration of movement episodes for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Average Duration of Night Time Movement Episodes | Week 0, n=24 | 8.257 Seconds | Standard Deviation 2.5147 |
| Mega Faros Device + Fast Fix | Average Duration of Night Time Movement Episodes | Week 4, n=22 | 7.664 Seconds | Standard Deviation 2.0949 |
| Mega Faros Device + Fast Fix | Average Duration of Night Time Movement Episodes | Week 8, n=19 | 8.133 Seconds | Standard Deviation 2.863 |
| Mega Faros Device + Fast Fix | Average Duration of Night Time Movement Episodes | Week 12, n=16 | 8.203 Seconds | Standard Deviation 2.3391 |
| Mega Faros Device + Fast Fix | Average Duration of Night Time Movement Episodes | Week 16, n=13 | 9.485 Seconds | Standard Deviation 5.4216 |
| Mega Faros Device + Fast Fix | Average Duration of Night Time Movement Episodes | Week 20, n=13 | 10.190 Seconds | Standard Deviation 7.2948 |
| Mega Faros Device + Fast Fix | Average Duration of Night Time Movement Episodes | Week 24, n=14 | 7.931 Seconds | Standard Deviation 1.8877 |
| Mega Faros Device + Fast Fix | Average Duration of Night Time Movement Episodes | Week 28, n=10 | 7.610 Seconds | Standard Deviation 1.5252 |
| Mega Faros Device + Fast Fix | Average Duration of Night Time Movement Episodes | Week 32, n=11 | 10.220 Seconds | Standard Deviation 6.3726 |
| Mega Faros Device + Fast Fix | Average Duration of Night Time Movement Episodes | Week 36, n=9 | 7.203 Seconds | Standard Deviation 0.6451 |
| Mega Faros Device + Fast Fix | Average Duration of Night Time Movement Episodes | Week 40, n=11 | 8.025 Seconds | Standard Deviation 1.8174 |
| Mega Faros Device + Fast Fix | Average Duration of Night Time Movement Episodes | Week 44, n=11 | 7.730 Seconds | Standard Deviation 2.3985 |
| Mega Faros Device + Fast Fix | Average Duration of Night Time Movement Episodes | Week 48, n=12 | 8.393 Seconds | Standard Deviation 2.5605 |
Other Pre-specified
Average Phoneme Rate
Phoneme rate was analyzed for the single word doily. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Average Phoneme Rate | Week0; n=25 | 6176.377 Hertz per second | Standard Deviation 2196.778 |
| Mega Faros Device + Fast Fix | Average Phoneme Rate | Week12; n=18 | 6903.574 Hertz per second | Standard Deviation 2484.952 |
| Mega Faros Device + Fast Fix | Average Phoneme Rate | Week24; n=17 | 5859.531 Hertz per second | Standard Deviation 3433.272 |
| Mega Faros Device + Fast Fix | Average Phoneme Rate | Week36; n=15 | 6937.497 Hertz per second | Standard Deviation 4868.936 |
| Mega Faros Device + Fast Fix | Average Phoneme Rate | Week48; n=18 | 5738.519 Hertz per second | Standard Deviation 3410.358 |
| Mega Faros Device + Fast Fix | Average Phoneme Rate | EWD; n=2 | 8980.240 Hertz per second | Standard Deviation 709.4459 |
Other Pre-specified
Average Time Spent Active
Number of minutes spent active per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Average Time Spent Active | Day time, Week 0, n=24 | 34.420 Minutes | Standard Deviation 29.3837 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Day time, Week 4, n=22 | 32.233 Minutes | Standard Deviation 33.1012 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Day time, Week 8, n=19 | 24.319 Minutes | Standard Deviation 25.5092 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Day time, Week 12, n=16 | 23.904 Minutes | Standard Deviation 17.2952 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Day time, Week 16, n=13 | 25.863 Minutes | Standard Deviation 23.2673 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Day time, Week 20, n=14 | 18.931 Minutes | Standard Deviation 18.3595 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Day time, Week 24, n=14 | 12.137 Minutes | Standard Deviation 10.8409 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Day time, Week 28, n=10 | 19.856 Minutes | Standard Deviation 29.0562 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Day time, Week 32, n=12 | 11.873 Minutes | Standard Deviation 15.0988 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Day time, Week 36, n=12 | 14.118 Minutes | Standard Deviation 19.7452 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Day time, Week 40, n=12 | 14.563 Minutes | Standard Deviation 18.7912 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Day time, Week 44, n=12 | 20.210 Minutes | Standard Deviation 26.0361 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Day time, Week 48, n=13 | 23.578 Minutes | Standard Deviation 29.0419 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Night time, Week 0, n=24 | 1.136 Minutes | Standard Deviation 1.5427 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Night time, Week 4, n=22 | 0.570 Minutes | Standard Deviation 0.6817 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Night time, Week 8, n=19 | 2.375 Minutes | Standard Deviation 5.754 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Night time, Week 12, n=16 | 0.484 Minutes | Standard Deviation 0.5404 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Night time, Week 16, n=13 | 0.449 Minutes | Standard Deviation 0.4684 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Night time, Week 20, n=14 | 0.418 Minutes | Standard Deviation 0.5315 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Night time, Week 24, n=14 | 0.387 Minutes | Standard Deviation 0.2715 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Night time, Week 28, n=10 | 1.432 Minutes | Standard Deviation 3.0455 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Night time, Week 32, n=12 | 0.668 Minutes | Standard Deviation 1.5814 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Night time, Week 36, n=12 | 0.414 Minutes | Standard Deviation 0.3682 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Night time, Week 40, n=12 | 0.268 Minutes | Standard Deviation 0.3272 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Night time, Week 44, n=12 | 0.390 Minutes | Standard Deviation 0.7308 |
| Mega Faros Device + Fast Fix | Average Time Spent Active | Night time, Week 48, n=13 | 0.518 Minutes | Standard Deviation 0.8014 |
Other Pre-specified
Average Time Spent Lying
Number of minutes spent lying per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Day time, Week 0, n=24 | 79.027 Minutes | Standard Deviation 59.8512 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Day time, Week 4, n=22 | 79.996 Minutes | Standard Deviation 67.1924 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Day time, Week 8, n=19 | 90.324 Minutes | Standard Deviation 80.8799 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Day time, Week 12, n=16 | 82.146 Minutes | Standard Deviation 59.7457 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Day time, Week 16, n=13 | 87.271 Minutes | Standard Deviation 75.4731 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Day time, Week 20, n=14 | 89.648 Minutes | Standard Deviation 90.802 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Day time, Week 24, n=14 | 82.979 Minutes | Standard Deviation 89.4852 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Day time, Week 28, n=10 | 136.170 Minutes | Standard Deviation 127.2225 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Day time, Week 32, n=12 | 99.760 Minutes | Standard Deviation 118.3536 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Day time, Week 36, n=12 | 50.278 Minutes | Standard Deviation 48.7456 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Day time, Week 40, n=12 | 103.749 Minutes | Standard Deviation 133.3234 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Day time, Week 44, n=12 | 71.757 Minutes | Standard Deviation 73.5817 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Day time, Week 48, n=13 | 141.575 Minutes | Standard Deviation 140.145 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Night time, Week 0, n=24 | 384.886 Minutes | Standard Deviation 135.8136 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Night time, Week 4, n=22 | 384.879 Minutes | Standard Deviation 97.8424 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Night time, Week 8, n=19 | 411.110 Minutes | Standard Deviation 157.882 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Night time, Week 12, n=16 | 417.943 Minutes | Standard Deviation 71.9066 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Night time, Week 16, n=13 | 413.721 Minutes | Standard Deviation 129.3161 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Night time, Week 20, n=14 | 407.060 Minutes | Standard Deviation 175.2092 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Night time, Week 24, n=14 | 318.155 Minutes | Standard Deviation 112.8749 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Night time, Week 28, n=10 | 454.137 Minutes | Standard Deviation 184.2617 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Night time, Week 32, n=12 | 412.196 Minutes | Standard Deviation 170.4452 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Night time, Week 36, n=12 | 217.884 Minutes | Standard Deviation 181.3682 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Night time, Week 40, n=12 | 355.222 Minutes | Standard Deviation 104.868 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Night time, Week 44, n=12 | 319.022 Minutes | Standard Deviation 155.2519 |
| Mega Faros Device + Fast Fix | Average Time Spent Lying | Night time, Week 48, n=13 | 333.358 Minutes | Standard Deviation 154.9236 |
Other Pre-specified
Average Time Spent Sedentary.
Number of minutes spent sedentary \[time spent lying + time spent sedentary not lying\] per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Day time, Week 0, n=24 | 602.219 Minutes | Standard Deviation 131.743 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Day time, Week 4, n=22 | 604.116 Minutes | Standard Deviation 165.0799 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Day time, Week 8, n=19 | 518.684 Minutes | Standard Deviation 234.6306 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Day time, Week 12, n=16 | 591.779 Minutes | Standard Deviation 118.3797 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Day time, Week 16, n=13 | 649.195 Minutes | Standard Deviation 117.2721 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Day time, Week 20, n=14 | 579.571 Minutes | Standard Deviation 213.9093 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Day time, Week 24, n=14 | 459.096 Minutes | Standard Deviation 233.1413 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Day time, Week 28, n=10 | 608.409 Minutes | Standard Deviation 141.5444 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Day time, Week 32, n=12 | 520.468 Minutes | Standard Deviation 285.7109 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Day time, Week 36, n=12 | 426.962 Minutes | Standard Deviation 250.239 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Day time, Week 40, n=12 | 569.629 Minutes | Standard Deviation 171.5586 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Day time, Week 44, n=12 | 512.132 Minutes | Standard Deviation 203.0705 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Day time, Week 48, n=13 | 651.109 Minutes | Standard Deviation 156.3296 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Night time, Week 0, n=24 | 400.408 Minutes | Standard Deviation 132.342 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Night time, Week 4, n=22 | 395.438 Minutes | Standard Deviation 100.9179 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Night time, Week 8, n=19 | 419.549 Minutes | Standard Deviation 162.0795 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Night time, Week 12, n=16 | 425.909 Minutes | Standard Deviation 69.7741 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Night time, Week 16, n=13 | 422.574 Minutes | Standard Deviation 132.3307 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Night time, Week 20, n=14 | 416.299 Minutes | Standard Deviation 179.9825 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Night time, Week 24, n=14 | 325.427 Minutes | Standard Deviation 114.9446 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Night time, Week 28, n=10 | 471.626 Minutes | Standard Deviation 196.1417 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Night time, Week 32, n=12 | 425.125 Minutes | Standard Deviation 178.8053 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Night time, Week 36, n=12 | 221.430 Minutes | Standard Deviation 184.4017 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Night time, Week 40, n=12 | 364.152 Minutes | Standard Deviation 105.2901 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Night time, Week 44, n=12 | 325.343 Minutes | Standard Deviation 156.8669 |
| Mega Faros Device + Fast Fix | Average Time Spent Sedentary. | Night time, Week 48, n=13 | 340.960 Minutes | Standard Deviation 157.686 |
Other Pre-specified
Average Time Spent 'Sedentary Not Lying'
Number of minutes spent 'sedentary not lying' per day and night for 24-hour recording period; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Day time, Week 0, n=24 | 523.191 Minutes | Standard Deviation 113.3016 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Day time, Week 4, n=22 | 524.120 Minutes | Standard Deviation 182.7753 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Day time, Week 8, n=19 | 428.359 Minutes | Standard Deviation 210.1894 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Day time, Week 12, n=16 | 509.634 Minutes | Standard Deviation 105.3263 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Day time, Week 16, n=13 | 561.923 Minutes | Standard Deviation 100.3003 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Day time, Week 20, n=14 | 489.921 Minutes | Standard Deviation 202.2926 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Day time, Week 24, n=14 | 376.117 Minutes | Standard Deviation 222.6009 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Day time, Week 28, n=10 | 472.238 Minutes | Standard Deviation 215.7768 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Day time, Week 32, n=12 | 420.709 Minutes | Standard Deviation 259.0856 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Day time, Week 36, n=12 | 376.686 Minutes | Standard Deviation 233.199 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Day time, Week 40, n=12 | 465.879 Minutes | Standard Deviation 181.5005 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Day time, Week 44, n=12 | 440.376 Minutes | Standard Deviation 198.2569 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Day time, Week 48, n=13 | 509.536 Minutes | Standard Deviation 171.156 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Night time, Week 0, n=24 | 15.522 Minutes | Standard Deviation 28.5337 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Night time, Week 4, n=22 | 10.561 Minutes | Standard Deviation 12.5485 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Night time, Week 8, n=19 | 8.441 Minutes | Standard Deviation 5.8601 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Night time, Week 12, n=16 | 7.968 Minutes | Standard Deviation 4.8657 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Night time, Week 16, n=13 | 8.855 Minutes | Standard Deviation 5.1855 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Night time, Week 20, n=14 | 9.239 Minutes | Standard Deviation 6.9942 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Night time, Week 24, n=14 | 7.274 Minutes | Standard Deviation 6.561 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Night time, Week 28, n=10 | 17.488 Minutes | Standard Deviation 15.1698 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Night time, Week 32, n=12 | 12.930 Minutes | Standard Deviation 14.8779 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Night time, Week 36, n=12 | 3.545 Minutes | Standard Deviation 3.5805 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Night time, Week 40, n=12 | 8.932 Minutes | Standard Deviation 5.0236 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Night time, Week 44, n=12 | 6.321 Minutes | Standard Deviation 4.5166 |
| Mega Faros Device + Fast Fix | Average Time Spent 'Sedentary Not Lying' | Night time, Week 48, n=13 | 7.602 Minutes | Standard Deviation 7.4373 |
Other Pre-specified
Duration of Maximum Gap Between Words
Duration of maximum gap between words during running speech to planned to analyze quality of speech however; was not performed.
Time frame: Up to Week 48
Population: Full Analysis Set
Other Pre-specified
Duration of Night Time Wear Time of the Device
Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of night time wear time was the calculated as the total of the times spent \[Active + day time lying + day time sedentary not lying\] for the night time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1.
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week36,Day 3, n=6 | 380.748 Minutes | Standard Deviation 298.7767 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week 0, Day 1, n=24 | 448.174 Minutes | Standard Deviation 222.1658 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week 0, Day 2, n=24 | 360.575 Minutes | Standard Deviation 212.4216 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week 0, Day 3, n=23 | 482.500 Minutes | Standard Deviation 150.8251 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week 0, Day 4, n=12 | 134.570 Minutes | Standard Deviation 239.8401 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week 0, Day 5, n=2 | 494.170 Minutes | Standard Deviation 57.9828 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week4, Day 1, n=22 | 487.682 Minutes | Standard Deviation 189.6054 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week4, Day 2, n=22 | 432.273 Minutes | Standard Deviation 209.9463 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week4, Day 3, n=21 | 455.047 Minutes | Standard Deviation 194.3802 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week4, Day 4, n=9 | 107.796 Minutes | Standard Deviation 205.8403 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week4, Day 5, n=5 | 109.400 Minutes | Standard Deviation 241.1904 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week4, Day 6, n=1 | 624.500 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week4, Day 7, n=1 | 462.340 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week4, Day 8, n=1 | 0.000 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week8, Day 1, n=19 | 506.316 Minutes | Standard Deviation 184.6635 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week8, Day 2, n=17 | 477.441 Minutes | Standard Deviation 206.7924 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week8, Day 3, n=17 | 526.825 Minutes | Standard Deviation 207.6252 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week8, Day 4, n=8 | 30.041 Minutes | Standard Deviation 84.9695 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week12,Day 1, n=16 | 255.708 Minutes | Standard Deviation 250.9718 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week12,Day 2, n=16 | 418.489 Minutes | Standard Deviation 149.6411 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week12,Day 3, n=15 | 519.888 Minutes | Standard Deviation 63.0517 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week12,Day 4, n=7 | 568.381 Minutes | Standard Deviation 150.256 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week12,Day 5, n=1 | 406.340 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week16,Day 1, n=13 | 513.448 Minutes | Standard Deviation 78.9644 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week16,Day 2, n=13 | 382.038 Minutes | Standard Deviation 185.6318 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week16,Day 3, n=12 | 494.932 Minutes | Standard Deviation 196.5556 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week16,Day 4, n=6 | 96.000 Minutes | Standard Deviation 220.5519 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week20,Day 1, n=14 | 445.811 Minutes | Standard Deviation 170.449 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week20,Day 2, n=13 | 452.345 Minutes | Standard Deviation 203.3159 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week20,Day 3, n=12 | 498.806 Minutes | Standard Deviation 138.8339 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week20,Day 4, n=4 | 148.458 Minutes | Standard Deviation 172.2844 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week24,Day 1, n=14 | 254.095 Minutes | Standard Deviation 261.1246 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week24,Day 2, n=12 | 398.068 Minutes | Standard Deviation 199.7096 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week24,Day 3, n=11 | 374.121 Minutes | Standard Deviation 214.6214 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week24,Day 4, n=8 | 291.376 Minutes | Standard Deviation 277.4058 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week24,Day 5, n=2 | 476.995 Minutes | Standard Deviation 1.888 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week28,Day 1, n=10 | 497.701 Minutes | Standard Deviation 242.6652 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week28,Day 2, n=10 | 483.950 Minutes | Standard Deviation 195.5384 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week28,Day 3, n=9 | 543.759 Minutes | Standard Deviation 270.4945 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week28,Day 4, n=6 | 286.778 Minutes | Standard Deviation 327.2635 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week32,Day 1, n=12 | 510.447 Minutes | Standard Deviation 218.5192 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week32,Day 2, n=10 | 460.233 Minutes | Standard Deviation 209.0824 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week32,Day 3, n=9 | 433.778 Minutes | Standard Deviation 256.9437 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week32,Day 4, n=1 | 0.000 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week36,Day 1, n=12 | 189.124 Minutes | Standard Deviation 199.229 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week36,Day 2, n=9 | 263.352 Minutes | Standard Deviation 236.3438 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week36,Day 4, n=4 | 358.503 Minutes | Standard Deviation 280.5689 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week36,Day 5, n=2 | 201.250 Minutes | Standard Deviation 284.6105 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week36,Day 6, n=1 | 505.170 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week40,Day 1, n=12 | 375.043 Minutes | Standard Deviation 192.0867 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week40,Day 2, n=12 | 442.528 Minutes | Standard Deviation 179.2818 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week40,Day 3, n=11 | 419.334 Minutes | Standard Deviation 215.047 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week40,Day 4, n=7 | 121.573 Minutes | Standard Deviation 172.7203 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week40,Day 5, n=1 | 522.500 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week40,Day 6, n=1 | 163.170 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week44,Day 1, n=12 | 393.140 Minutes | Standard Deviation 192.6969 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week44,Day 2, n=11 | 362.275 Minutes | Standard Deviation 208.9128 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week44,Day 3, n=10 | 382.018 Minutes | Standard Deviation 201.1957 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week44,Day 4, n=4 | 111.543 Minutes | Standard Deviation 223.085 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week44,Day 5, n=1 | 277.330 Minutes | — |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week48,Day 1, n=13 | 439.486 Minutes | Standard Deviation 153.347 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week48,Day 2, n=13 | 381.988 Minutes | Standard Deviation 192.954 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week48,Day 3, n=10 | 299.985 Minutes | Standard Deviation 146.9104 |
| Mega Faros Device + Fast Fix | Duration of Night Time Wear Time of the Device | Week48,Day 4, n=5 | 81.400 Minutes | Standard Deviation 182.0159 |
Other Pre-specified
Effect of Activity on HRV Variance (LF/HF Analysis)
The effect of activity on HRV variance was calculated as \[HRV variance while sedentary not lying minus HRV variance while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1.
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Effect of Activity on HRV Variance (LF/HF Analysis) | Week 0; n= 2 | -8.6500 Ratio | Standard Deviation 5.93027 |
| Mega Faros Device + Fast Fix | Effect of Activity on HRV Variance (LF/HF Analysis) | Week 4; n= 1 | -3.4367 Ratio | — |
Other Pre-specified
Effect of Activity on Mean HRV (LF/HF)
The effect of activity on mean HRV was calculated as \[mean HRV while sedentary not lying minus mean HRV while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1.
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Effect of Activity on Mean HRV (LF/HF) | Week 0; n= 2 | -1.6117 Ratio | Standard Deviation 2.88735 |
| Mega Faros Device + Fast Fix | Effect of Activity on Mean HRV (LF/HF) | Week 4; n= 1 | 0.9367 Ratio | — |
Other Pre-specified
Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis)
The effect of being upright on mean HRV was calculated as \[mean HRV while sedentary not lying minus mean HRV while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) | Week 0, n=20 | 1.0563 Ratio | Standard Deviation 2.12227 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) | Week 4, n=18 | 1.3507 Ratio | Standard Deviation 2.56807 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) | Week 8, n=13 | 1.1937 Ratio | Standard Deviation 2.40299 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) | Week 12, n=14 | 2.1585 Ratio | Standard Deviation 2.80355 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) | Week 16, n=11 | 2.5080 Ratio | Standard Deviation 3.40632 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) | Week 20, n=10 | 2.4613 Ratio | Standard Deviation 3.64555 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) | Week 24, n=10 | 2.5161 Ratio | Standard Deviation 1.95702 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) | Week 28, n=9 | -0.1964 Ratio | Standard Deviation 6.11226 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) | Week 32, n=9 | 3.3476 Ratio | Standard Deviation 5.59881 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) | Week 36, n=9 | 2.5583 Ratio | Standard Deviation 3.74969 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) | Week 40, n=9 | 0.9722 Ratio | Standard Deviation 1.73768 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) | Week 44, n=9 | 1.6069 Ratio | Standard Deviation 2.71641 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) | Week 48, n=6 | 1.5796 Ratio | Standard Deviation 3.73597 |
Other Pre-specified
Effect of Being Upright on HRV Variance (LF/HF Analysis)
The effect of being upright on HRV variance was calculated as \[HRV variance while sedentary not lying minus HRV variance while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV Variance (LF/HF Analysis) | Week 0, n=20 | -0.0750 Ratio | Standard Deviation 5.2142 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV Variance (LF/HF Analysis) | Week 4, n=18 | -5.5005 Ratio | Standard Deviation 28.71903 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV Variance (LF/HF Analysis) | Week 8, n=13 | -2.0885 Ratio | Standard Deviation 9.89872 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV Variance (LF/HF Analysis) | Week 12, n=14 | 4.1473 Ratio | Standard Deviation 8.03699 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV Variance (LF/HF Analysis) | Week 16, n=11 | 9.8909 Ratio | Standard Deviation 21.83721 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV Variance (LF/HF Analysis) | Week 20, n=10 | 2.9204 Ratio | Standard Deviation 17.31637 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV Variance (LF/HF Analysis) | Week 24, n=10 | -1.1979 Ratio | Standard Deviation 2.96892 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV Variance (LF/HF Analysis) | Week 28, n=9 | -13.6310 Ratio | Standard Deviation 45.52591 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV Variance (LF/HF Analysis) | Week 32, n=9 | -8.9054 Ratio | Standard Deviation 19.69942 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV Variance (LF/HF Analysis) | Week 36, n=9 | 10.3525 Ratio | Standard Deviation 35.50938 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV Variance (LF/HF Analysis) | Week 40, n=9 | -3.8092 Ratio | Standard Deviation 8.66934 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV Variance (LF/HF Analysis) | Week 44, n=9 | -2.1221 Ratio | Standard Deviation 11.81571 |
| Mega Faros Device + Fast Fix | Effect of Being Upright on HRV Variance (LF/HF Analysis) | Week 48, n=6 | 4.3165 Ratio | Standard Deviation 16.66785 |
Other Pre-specified
HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis
HRV variance over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis | Week 24, n=12 | 34.3781 Milliseconds^2 | Standard Deviation 38.27469 |
| Mega Faros Device + Fast Fix | HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis | Week 0, n=24 | 35.3316 Milliseconds^2 | Standard Deviation 25.70628 |
| Mega Faros Device + Fast Fix | HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis | Week 4, n=21 | 26.2719 Milliseconds^2 | Standard Deviation 19.19169 |
| Mega Faros Device + Fast Fix | HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis | Week 8, n=15 | 34.5477 Milliseconds^2 | Standard Deviation 18.01341 |
| Mega Faros Device + Fast Fix | HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis | Week 12, n=16 | 31.8929 Milliseconds^2 | Standard Deviation 28.36635 |
| Mega Faros Device + Fast Fix | HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis | Week 16, n=12 | 34.8321 Milliseconds^2 | Standard Deviation 25.62477 |
| Mega Faros Device + Fast Fix | HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis | Week 20, n=12 | 41.4669 Milliseconds^2 | Standard Deviation 36.88159 |
| Mega Faros Device + Fast Fix | HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis | Week 28, n=10 | 45.4243 Milliseconds^2 | Standard Deviation 62.35269 |
| Mega Faros Device + Fast Fix | HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis | Week 32, n=10 | 30.5288 Milliseconds^2 | Standard Deviation 24.91715 |
| Mega Faros Device + Fast Fix | HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis | Week 36, n=11 | 24.8373 Milliseconds^2 | Standard Deviation 14.41668 |
| Mega Faros Device + Fast Fix | HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis | Week 40, n=11 | 18.4227 Milliseconds^2 | Standard Deviation 9.54924 |
| Mega Faros Device + Fast Fix | HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis | Week 44, n=11 | 22.5279 Milliseconds^2 | Standard Deviation 10.78475 |
| Mega Faros Device + Fast Fix | HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis | Week 48, n=12 | 15.7176 Milliseconds^2 | Standard Deviation 13.1576 |
Other Pre-specified
Maximum Activity Count in a 24 Hour Period
Maximum activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Day time, Week 0, n=24 | 2803.906 Count of activity | Standard Deviation 2819.342 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Day time, Week 4, n=22 | 1915.344 Count of activity | Standard Deviation 1787.325 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Day time, Week 8, n=17 | 3520.196 Count of activity | Standard Deviation 6145.555 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Day time, Week 12, n=16 | 2004.569 Count of activity | Standard Deviation 1341.035 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Day time, Week 16, n=13 | 2337.092 Count of activity | Standard Deviation 2537.966 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Day time, Week 20, n=14 | 1923.578 Count of activity | Standard Deviation 1690 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Day time, Week 24, n=13 | 1050.409 Count of activity | Standard Deviation 831.3745 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Day time, Week 28, n=10 | 960.596 Count of activity | Standard Deviation 667.9179 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Day time, Week 32, n=12 | 815.954 Count of activity | Standard Deviation 772.5387 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Day time, Week 36, n=12 | 1238.367 Count of activity | Standard Deviation 1121.657 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Day time, Week 40, n=12 | 897.363 Count of activity | Standard Deviation 785.0252 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Day time, Week 44, n=12 | 1940.100 Count of activity | Standard Deviation 2346.428 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Day time, Week 48, n=13 | 1647.037 Count of activity | Standard Deviation 1645.568 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Night time, Week 0, n=24 | 657.385 Count of activity | Standard Deviation 823.5054 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Night time, Week 4, n=22 | 511.867 Count of activity | Standard Deviation 599.0219 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Night time, Week 8, n=19 | 676.360 Count of activity | Standard Deviation 1168.379 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Night time, Week 12, n=16 | 280.178 Count of activity | Standard Deviation 222.3819 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Night time, Week 16, n=13 | 440.992 Count of activity | Standard Deviation 641.4221 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Night time, Week 20, n=13 | 306.540 Count of activity | Standard Deviation 293.6219 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Night time, Week 24, n=14 | 442.779 Count of activity | Standard Deviation 611.487 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Night time, Week 28, n=10 | 708.219 Count of activity | Standard Deviation 967.2115 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Night time, Week 32, n=12 | 479.673 Count of activity | Standard Deviation 590.4367 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Night time, Week 36, n=10 | 462.395 Count of activity | Standard Deviation 313.6826 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Night time, Week 40, n=12 | 278.703 Count of activity | Standard Deviation 264.5554 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Night time, Week 44, n=11 | 383.820 Count of activity | Standard Deviation 273.3449 |
| Mega Faros Device + Fast Fix | Maximum Activity Count in a 24 Hour Period | Night time, Week 48, n=13 | 493.870 Count of activity | Standard Deviation 524.4698 |
Other Pre-specified
Maximum Phonation Time
Maximum phonation time for the single word doily test was analyzed for quality of speech testing. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Seconds
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Maximum Phonation Time | Week0; n=25 | 0.174 Seconds | Standard Deviation 0.0724 |
| Mega Faros Device + Fast Fix | Maximum Phonation Time | Week12; n=18 | 0.188 Seconds | Standard Deviation 0.0862 |
| Mega Faros Device + Fast Fix | Maximum Phonation Time | Week24; n=17 | 0.186 Seconds | Standard Deviation 0.1005 |
| Mega Faros Device + Fast Fix | Maximum Phonation Time | Week36; n=15 | 0.154 Seconds | Standard Deviation 0.0608 |
| Mega Faros Device + Fast Fix | Maximum Phonation Time | Week48; n=18 | 0.147 Seconds | Standard Deviation 0.0884 |
| Mega Faros Device + Fast Fix | Maximum Phonation Time | EWD; n=2 | 0.212 Seconds | Standard Deviation 0.0639 |
Other Pre-specified
Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF])
Mean Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) | Week 0, n=23 | 4.1914 Ratio | Standard Deviation 2.3537 |
| Mega Faros Device + Fast Fix | Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) | Week 4, n=21 | 4.2198 Ratio | Standard Deviation 2.88326 |
| Mega Faros Device + Fast Fix | Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) | Week 8, n=15 | 4.2393 Ratio | Standard Deviation 2.5084 |
| Mega Faros Device + Fast Fix | Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) | Week 12, n=15 | 4.2304 Ratio | Standard Deviation 2.13905 |
| Mega Faros Device + Fast Fix | Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) | Week 16, n=12 | 3.7404 Ratio | Standard Deviation 1.9981 |
| Mega Faros Device + Fast Fix | Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) | Week 20, n=12 | 4.6210 Ratio | Standard Deviation 3.4072 |
| Mega Faros Device + Fast Fix | Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) | Week 24, n=12 | 4.2944 Ratio | Standard Deviation 2.43365 |
| Mega Faros Device + Fast Fix | Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) | Week 28, n=10 | 6.1888 Ratio | Standard Deviation 5.64815 |
| Mega Faros Device + Fast Fix | Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) | Week 32, n=10 | 5.0398 Ratio | Standard Deviation 3.64394 |
| Mega Faros Device + Fast Fix | Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) | Week 36, n=9 | 4.9206 Ratio | Standard Deviation 3.44514 |
| Mega Faros Device + Fast Fix | Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) | Week 40, n=11 | 4.6117 Ratio | Standard Deviation 2.81758 |
| Mega Faros Device + Fast Fix | Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) | Week 44, n=11 | 3.8315 Ratio | Standard Deviation 2.29689 |
| Mega Faros Device + Fast Fix | Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) | Week 48, n=11 | 4.4358 Ratio | Standard Deviation 2.56115 |
Other Pre-specified
Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD)
Mean HRV over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) | Week 0, n=24 | 21.2445 Milliseconds^2 | Standard Deviation 6.13882 |
| Mega Faros Device + Fast Fix | Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) | Week 4, n=21 | 20.0394 Milliseconds^2 | Standard Deviation 6.61338 |
| Mega Faros Device + Fast Fix | Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) | Week 8, n=15 | 22.4551 Milliseconds^2 | Standard Deviation 5.98867 |
| Mega Faros Device + Fast Fix | Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) | Week 12, n=16 | 20.6744 Milliseconds^2 | Standard Deviation 6.95469 |
| Mega Faros Device + Fast Fix | Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) | Week 16, n=12 | 20.7926 Milliseconds^2 | Standard Deviation 7.01048 |
| Mega Faros Device + Fast Fix | Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) | Week 20, n=12 | 20.7321 Milliseconds^2 | Standard Deviation 6.80432 |
| Mega Faros Device + Fast Fix | Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) | Week 24, n=12 | 21.3250 Milliseconds^2 | Standard Deviation 6.92749 |
| Mega Faros Device + Fast Fix | Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) | Week 28, n=10 | 21.7888 Milliseconds^2 | Standard Deviation 7.14731 |
| Mega Faros Device + Fast Fix | Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) | Week 32, n=10 | 21.1318 Milliseconds^2 | Standard Deviation 8.08213 |
| Mega Faros Device + Fast Fix | Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) | Week 36, n=11 | 20.8849 Milliseconds^2 | Standard Deviation 5.72665 |
| Mega Faros Device + Fast Fix | Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) | Week 40, n=11 | 20.0684 Milliseconds^2 | Standard Deviation 7.98572 |
| Mega Faros Device + Fast Fix | Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) | Week 44, n=11 | 20.2980 Milliseconds^2 | Standard Deviation 5.95832 |
| Mega Faros Device + Fast Fix | Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) | Week 48, n=12 | 19.5152 Milliseconds^2 | Standard Deviation 8.04882 |
Other Pre-specified
Mean HRV While Active (LF/HF)
Mean Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data is not available. Standard deviation could not be calculated when number of participants was \<=1
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Mean HRV While Active (LF/HF) | Week 0, n=2 | 4.3350 Ratio | Standard Deviation 0.09192 |
| Mega Faros Device + Fast Fix | Mean HRV While Active (LF/HF) | Week 4, n=1 | 3.8100 Ratio | — |
Other Pre-specified
Mean HRV While Sedentary Not Lying (LF/HF)
Mean Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Mean HRV While Sedentary Not Lying (LF/HF) | Week 0, n=20 | 5.2011 Ratio | Standard Deviation 2.48369 |
| Mega Faros Device + Fast Fix | Mean HRV While Sedentary Not Lying (LF/HF) | Week 4, n=18 | 5.3944 Ratio | Standard Deviation 2.83547 |
| Mega Faros Device + Fast Fix | Mean HRV While Sedentary Not Lying (LF/HF) | Week 8, n=13 | 5.1733 Ratio | Standard Deviation 2.29737 |
| Mega Faros Device + Fast Fix | Mean HRV While Sedentary Not Lying (LF/HF) | Week 12, n=14 | 6.3760 Ratio | Standard Deviation 3.42063 |
| Mega Faros Device + Fast Fix | Mean HRV While Sedentary Not Lying (LF/HF) | Week 16, n=11 | 6.0905 Ratio | Standard Deviation 3.68543 |
| Mega Faros Device + Fast Fix | Mean HRV While Sedentary Not Lying (LF/HF) | Week 20, n=10 | 6.0958 Ratio | Standard Deviation 3.05182 |
| Mega Faros Device + Fast Fix | Mean HRV While Sedentary Not Lying (LF/HF) | Week 24, n=10 | 6.3113 Ratio | Standard Deviation 3.03599 |
| Mega Faros Device + Fast Fix | Mean HRV While Sedentary Not Lying (LF/HF) | Week 28, n=9 | 5.4652 Ratio | Standard Deviation 3.20703 |
| Mega Faros Device + Fast Fix | Mean HRV While Sedentary Not Lying (LF/HF) | Week 32, n=9 | 8.3196 Ratio | Standard Deviation 5.37661 |
| Mega Faros Device + Fast Fix | Mean HRV While Sedentary Not Lying (LF/HF) | Week 36, n=11 | 6.6827 Ratio | Standard Deviation 2.73499 |
| Mega Faros Device + Fast Fix | Mean HRV While Sedentary Not Lying (LF/HF) | Week 40, n=9 | 4.8166 Ratio | Standard Deviation 2.16486 |
| Mega Faros Device + Fast Fix | Mean HRV While Sedentary Not Lying (LF/HF) | Week 44, n=9 | 5.6220 Ratio | Standard Deviation 2.61752 |
| Mega Faros Device + Fast Fix | Mean HRV While Sedentary Not Lying (LF/HF) | Week 48, n=7 | 5.8935 Ratio | Standard Deviation 3.22033 |
Other Pre-specified
Mean Maximum Activity Count in a 24 Hour Period
Mean maximum activity count of day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Day time, Week 0, n=24 | 1618.403 Count of activity | Standard Deviation 1288.502 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Day time, Week 4, n=22 | 1309.195 Count of activity | Standard Deviation 1042.15 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Day time, Week 8, n=17 | 1612.785 Count of activity | Standard Deviation 1822.405 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Day time, Week 12, n=16 | 1165.166 Count of activity | Standard Deviation 705.7684 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Day time, Week 16, n=13 | 1510.868 Count of activity | Standard Deviation 1407.533 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Day time, Week 20, n=14 | 1146.578 Count of activity | Standard Deviation 1016.899 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Day time, Week 24, n=13 | 697.693 Count of activity | Standard Deviation 678.2212 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Day time, Week 28, n=10 | 665.987 Count of activity | Standard Deviation 475.5967 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Day time, Week 32, n=12 | 633.595 Count of activity | Standard Deviation 536.0698 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Day time, Week 36, n=12 | 772.909 Count of activity | Standard Deviation 672.3572 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Day time, Week 40, n=12 | 543.052 Count of activity | Standard Deviation 410.3246 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Day time, Week 44, n=12 | 1074.333 Count of activity | Standard Deviation 988.7887 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Day time, Week 48, n=13 | 1002.060 Count of activity | Standard Deviation 1011.468 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Night time, Week 0, n=24 | 319.872 Count of activity | Standard Deviation 312.3125 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Night time, Week 4, n=22 | 231.630 Count of activity | Standard Deviation 183.242 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Night time, Week 8, n=19 | 518.646 Count of activity | Standard Deviation 1153.825 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Night time, Week 12, n=16 | 176.211 Count of activity | Standard Deviation 142.699 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Night time, Week 16, n=13 | 194.670 Count of activity | Standard Deviation 208.1798 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Night time, Week 20, n=13 | 174.990 Count of activity | Standard Deviation 153.0679 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Night time, Week 24, n=14 | 208.871 Count of activity | Standard Deviation 184.5488 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Night time, Week 28, n=10 | 325.419 Count of activity | Standard Deviation 356.4562 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Night time, Week 32, n=12 | 267.311 Count of activity | Standard Deviation 294.0265 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Night time, Week 36, n=10 | 242.772 Count of activity | Standard Deviation 159.5699 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Night time, Week 40, n=12 | 145.523 Count of activity | Standard Deviation 109.5598 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Night time, Week 44, n=11 | 207.506 Count of activity | Standard Deviation 134.7506 |
| Mega Faros Device + Fast Fix | Mean Maximum Activity Count in a 24 Hour Period | Night time, Week 48, n=13 | 233.548 Count of activity | Standard Deviation 215.707 |
Other Pre-specified
Measurement of Speech Quality
Speech quality was assessed by Central Tendency of Fundamental Frequency (CTF) F0, jitter, and shimmer for 'short ah' and 'long ah' tests. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | CTF F0;Week0;n=25 (Short ah) | 151.829 Hertz | Standard Deviation 44.5983 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | CTF F0;Week12;n=18 (Short ah) | 156.506 Hertz | Standard Deviation 42.0801 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | CTF F0;Week24;n=17 (Short ah) | 143.481 Hertz | Standard Deviation 43.8646 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | CTF F0;Week36;n=15 (Short ah) | 151.192 Hertz | Standard Deviation 43.1685 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | CTF F0;Week48;n=18 (Short ah) | 156.418 Hertz | Standard Deviation 71.9125 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | CTF F0;EWD;n=3 (Short ah) | 176.229 Hertz | Standard Deviation 76.2851 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Jitter;Week0;n=25 (Short ah) | 0.405 Hertz | Standard Deviation 0.2814 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Jitter;Week12;n=18 (Short ah) | 0.531 Hertz | Standard Deviation 0.2956 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Jitter;Week24;n=17 (Short ah) | 0.415 Hertz | Standard Deviation 0.3345 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Jitter;Week36;n=15 (Short ah) | 0.429 Hertz | Standard Deviation 0.2987 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Jitter;Week48;n=18 (Short ah) | 0.379 Hertz | Standard Deviation 0.2949 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Jitter;EWD;n=2 (Short ah) | 0.435 Hertz | Standard Deviation 0.1835 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Shimmer;Week0;n=25 (Short ah) | 5.099 Hertz | Standard Deviation 1.0892 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Shimmer;Week12;n=18 (Short ah) | 5.031 Hertz | Standard Deviation 1.085 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Shimmer;Week24;n=17 (Short ah) | 5.498 Hertz | Standard Deviation 1.1896 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Shimmer;Week36;n=15 (Short ah) | 5.203 Hertz | Standard Deviation 1.4083 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Shimmer;Week48;n=18 (Short ah) | 5.157 Hertz | Standard Deviation 1.9564 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Shimmer;EWD;n=2 (Short ah) | 5.624 Hertz | Standard Deviation 1.5979 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | CTF F0;Week0;n=25 (Long ah) | 134.443 Hertz | Standard Deviation 33.2237 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | CTF F0;Week12;n=18 (Long ah) | 122.620 Hertz | Standard Deviation 35.6641 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | CTF F0;Week24;n=17 (Long ah) | 146.295 Hertz | Standard Deviation 63.0013 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | CTF F0;Week36;n=15 (Long ah) | 145.575 Hertz | Standard Deviation 45.5629 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | CTF F0;Week48;n=18 (Long ah) | 134.198 Hertz | Standard Deviation 48.3046 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | CTF F0;EWD;n=3 (Long ah) | 179.844 Hertz | Standard Deviation 25.7371 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Jitter;Week0;n=25 (Long ah) | 0.148 Hertz | Standard Deviation 0.1701 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Jitter;Week12;n=18 (Long ah) | 0.098 Hertz | Standard Deviation 0.0697 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Jitter;Week24;n=17 (Long ah) | 0.178 Hertz | Standard Deviation 0.303 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Jitter;Week36;n=15 (Long ah) | 0.229 Hertz | Standard Deviation 0.3069 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Jitter;Week48;n=18 (Long ah) | 0.148 Hertz | Standard Deviation 0.1309 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Jitter;EWD;n=2 (Long ah) | 0.304 Hertz | Standard Deviation 0.3115 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Shimmer;Week0;n=25 (Long ah) | 2.926 Hertz | Standard Deviation 1.0166 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Shimmer;Week12;n=18 (Long ah) | 3.192 Hertz | Standard Deviation 0.8599 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Shimmer;Week24;n=17 (Long ah) | 3.082 Hertz | Standard Deviation 1.1959 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Shimmer;Week36;n=15 (Long ah) | 2.872 Hertz | Standard Deviation 1.2162 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Shimmer;Week48;n=18 (Long ah) | 3.046 Hertz | Standard Deviation 1.4476 |
| Mega Faros Device + Fast Fix | Measurement of Speech Quality | Shimmer;EWD;n=2 (Long ah) | 2.767 Hertz | Standard Deviation 0.0709 |
Other Pre-specified
Number of Continuous Active Periods
Active periods were catagorized as \>1minute to \<=2minutes, \>2 minutes to \<=5minutes, \>5 minutes to \<=15 minutes, \>15 minutes to \<=30 minutes, \>30 minutes. Total number of 'active periods were calculated as 1minute\<x\<2minutes + 'number of active periods 2minutes\<x\<5minutes + 'number of active periods 5minutes\<x\<15minutes + 'number of active periods 15minutes\<x\<30minutes + 'number of active periods \>30minutes.
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes; Day time, Week 0, n=24 | 0.279 Number/Hour | Standard Deviation 0.3174 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Day time, Week 4, n=22 | 0.267 Number/Hour | Standard Deviation 0.3874 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Day time, Week 8, n=18 | 0.255 Number/Hour | Standard Deviation 0.323 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Day time, Week 12, n=16 | 0.188 Number/Hour | Standard Deviation 0.1925 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Day time, Week 16, n=13 | 0.191 Number/Hour | Standard Deviation 0.1996 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Day time, Week 20, n=14 | 0.169 Number/Hour | Standard Deviation 0.1812 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Day time, Week 24, n=14 | 0.206 Number/Hour | Standard Deviation 0.2088 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Day time, Week 28, n=10 | 0.147 Number/Hour | Standard Deviation 0.1564 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Day time, Week 32, n=12 | 0.100 Number/Hour | Standard Deviation 0.1172 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Day time, Week 36, n=12 | 0.164 Number/Hour | Standard Deviation 0.2649 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Day time, Week 40, n=12 | 0.170 Number/Hour | Standard Deviation 0.2644 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Day time, Week 44, n=12 | 0.174 Number/Hour | Standard Deviation 0.2518 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Day time, Week 48, n=13 | 0.252 Number/Hour | Standard Deviation 0.3609 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes; Day time, Week 0, n=24 | 0.108 Number/Hour | Standard Deviation 0.1263 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Day time, Week 4, n=22 | 0.097 Number/Hour | Standard Deviation 0.1264 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Day time, Week 8, n=18 | 0.084 Number/Hour | Standard Deviation 0.1675 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Day time, Week 12, n=16 | 0.108 Number/Hour | Standard Deviation 0.1201 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Day time, Week 16, n=13 | 0.123 Number/Hour | Standard Deviation 0.159 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Day time, Week 20, n=14 | 0.080 Number/Hour | Standard Deviation 0.1105 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Day time, Week 24, n=14 | 0.057 Number/Hour | Standard Deviation 0.0819 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Day time, Week 28, n=10 | 0.107 Number/Hour | Standard Deviation 0.17 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Day time, Week 32, n=12 | 0.058 Number/Hour | Standard Deviation 0.1129 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Day time, Week 36, n=12 | 0.079 Number/Hour | Standard Deviation 0.1538 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Day time, Week 40, n=12 | 0.072 Number/Hour | Standard Deviation 0.1137 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Day time, Week 44, n=12 | 0.071 Number/Hour | Standard Deviation 0.1417 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Day time, Week 48, n=13 | 0.095 Number/Hour | Standard Deviation 0.14 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes; Day time, Week 0, n=24 | 0.041 Number/Hour | Standard Deviation 0.074 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Day time, Week 4, n=22 | 0.030 Number/Hour | Standard Deviation 0.0471 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Day time, Week 8, n=18 | 0.020 Number/Hour | Standard Deviation 0.0333 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Day time, Week 12, n=16 | 0.023 Number/Hour | Standard Deviation 0.0364 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Day time, Week 16, n=13 | 0.042 Number/Hour | Standard Deviation 0.0699 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Day time, Week 20, n=14 | 0.016 Number/Hour | Standard Deviation 0.044 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Day time, Week 24, n=14 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Day time, Week 28, n=10 | 0.024 Number/Hour | Standard Deviation 0.0534 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Day time, Week 32, n=12 | 0.015 Number/Hour | Standard Deviation 0.0353 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Day time, Week 36, n=12 | 0.008 Number/Hour | Standard Deviation 0.0289 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Day time, Week 40, n=12 | 0.022 Number/Hour | Standard Deviation 0.0549 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Day time, Week 44, n=12 | 0.008 Number/Hour | Standard Deviation 0.0199 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Day time, Week 48, n=13 | 0.023 Number/Hour | Standard Deviation 0.044 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes; Day time, Week 0, n=24 | 0.003 Number/Hour | Standard Deviation 0.0108 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Day time, Week 4, n=22 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Day time, Week 8, n=18 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Day time, Week 12, n=16 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Day time, Week 16, n=13 | 0.003 Number/Hour | Standard Deviation 0.0111 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Day time, Week 20, n=14 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Day time, Week 24, n=14 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Day time, Week 28, n=10 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Day time, Week 32, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Day time, Week 36, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Day time, Week 40, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Day time, Week 44, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Day time, Week 48, n=13 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes; Day time, Week 0, n=24 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Day time, Week 4, n=22 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Day time, Week 8, n=18 | 0.001 Number/Hour | Standard Deviation 0.0047 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Day time, Week 12, n=16 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Day time, Week 16, n=13 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Day time, Week 20, n=14 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Day time, Week 24, n=14 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Day time, Week 28, n=10 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Day time, Week 32, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Day time, Week 36, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Day time, Week 40, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Day time, Week 44, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Day time, Week 48, n=13 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes; Night time, Week 0, n=24 | 0.015 Number/Hour | Standard Deviation 0.0365 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Night time, Week 4, n=22 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Night time, Week 8, n=19 | 0.046 Number/Hour | Standard Deviation 0.1453 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Night time, Week 12, n=16 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Night time, Week 16, n=13 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Night time, Week 20, n=13 | 0.003 Number/Hour | Standard Deviation 0.0111 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Night time, Week 24, n=14 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Night time, Week 28, n=10 | 0.004 Number/Hour | Standard Deviation 0.0126 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Night time, Week 32, n=12 | 0.004 Number/Hour | Standard Deviation 0.0144 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Night time, Week 36, n=10 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Night time, Week 40, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Night time, Week 44, n=11 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >1 to <=2minutes;Night time, Week 48, n=13 | 0.292 Number/Hour | Standard Deviation 1.0512 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes; Night time, Week 0, n=24 | 0.008 Number/Hour | Standard Deviation 0.0284 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Night time, Week 4, n=22 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Night time, Week 8, n=19 | 0.067 Number/Hour | Standard Deviation 0.2617 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Night time, Week 12, n=16 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Night time, Week 16, n=13 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Night time, Week 20, n=13 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Night time, Week 24, n=14 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Night time, Week 28, n=10 | 0.006 Number/Hour | Standard Deviation 0.019 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Night time, Week 32, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Night time, Week 36, n=10 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Night time, Week 40, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Night time, Week 44, n=11 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >2 to <=5minutes;Night time, Week 48, n=13 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes; Night time, Week 0, n=24 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Night time, Week 4, n=22 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Night time, Week 8, n=19 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Night time, Week 12, n=16 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Night time, Week 16, n=13 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Night time, Week 20, n=13 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Night time, Week 24, n=14 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Night time, Week 28, n=10 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Night time, Week 32, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Night time, Week 36, n=10 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Night time, Week 40, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Night time, Week 44, n=11 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >5 to <=15 minutes;Night time, Week 48, n=13 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes; Night time, Week 0, n=24 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Night time, Week 4, n=22 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Night time, Week 8, n=19 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Night time, Week 12, n=16 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Night time, Week 16, n=13 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Night time, Week 20, n=13 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Night time, Week 24, n=14 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Night time, Week 28, n=10 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Night time, Week 32, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Night time, Week 36, n=10 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Night time, Week 40, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Night time, Week 44, n=11 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >15 to <=30 minutes;Night time, Week 48, n=13 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes; Night time, Week 0, n=24 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Night time, Week 4, n=22 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Night time, Week 8, n=19 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Night time, Week 12, n=16 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Night time, Week 16, n=13 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Night time, Week 20, n=13 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Night time, Week 24, n=14 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Night time, Week 28, n=10 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Night time, Week 32, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Night time, Week 36, n=10 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Night time, Week 40, n=12 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Night time, Week 44, n=11 | 0.000 Number/Hour | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Number of Continuous Active Periods | >30 minutes;Night time, Week 48, n=13 | 0.000 Number/Hour | Standard Deviation 0 |
Other Pre-specified
Number of Night Time Movement Episodes Per Hour
Average number of night movement episodes per hour for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Number of Night Time Movement Episodes Per Hour | Week 0, n=24 | 6.129 Number of movements/hour | Standard Deviation 4.6585 |
| Mega Faros Device + Fast Fix | Number of Night Time Movement Episodes Per Hour | Week 4, n=22 | 6.982 Number of movements/hour | Standard Deviation 7.6835 |
| Mega Faros Device + Fast Fix | Number of Night Time Movement Episodes Per Hour | Week 8, n=19 | 9.258 Number of movements/hour | Standard Deviation 17.3296 |
| Mega Faros Device + Fast Fix | Number of Night Time Movement Episodes Per Hour | Week 12, n=16 | 3.803 Number of movements/hour | Standard Deviation 1.7339 |
| Mega Faros Device + Fast Fix | Number of Night Time Movement Episodes Per Hour | Week 16, n=13 | 6.852 Number of movements/hour | Standard Deviation 11.6765 |
| Mega Faros Device + Fast Fix | Number of Night Time Movement Episodes Per Hour | Week 20, n=13 | 4.788 Number of movements/hour | Standard Deviation 4.4738 |
| Mega Faros Device + Fast Fix | Number of Night Time Movement Episodes Per Hour | Week 24, n=14 | 4.216 Number of movements/hour | Standard Deviation 1.8617 |
| Mega Faros Device + Fast Fix | Number of Night Time Movement Episodes Per Hour | Week 28, n=10 | 5.295 Number of movements/hour | Standard Deviation 5.1177 |
| Mega Faros Device + Fast Fix | Number of Night Time Movement Episodes Per Hour | Week 32, n=12 | 8.708 Number of movements/hour | Standard Deviation 12.9217 |
| Mega Faros Device + Fast Fix | Number of Night Time Movement Episodes Per Hour | Week 36, n=10 | 12.149 Number of movements/hour | Standard Deviation 17.717 |
| Mega Faros Device + Fast Fix | Number of Night Time Movement Episodes Per Hour | Week 40, n=12 | 4.747 Number of movements/hour | Standard Deviation 4.5737 |
| Mega Faros Device + Fast Fix | Number of Night Time Movement Episodes Per Hour | Week 44, n=11 | 3.385 Number of movements/hour | Standard Deviation 1.8031 |
| Mega Faros Device + Fast Fix | Number of Night Time Movement Episodes Per Hour | Week 48, n=13 | 7.209 Number of movements/hour | Standard Deviation 13.6287 |
Other Pre-specified
Number of Participants Reporting Impact on Sleep
Participant feedback on how much the sensor impacted their sleep was categorized as not at all, moderately and minimally. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Not at all;Pilot; n=5 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Moderately;Pilot; n=5 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Minimally; Pilot; n=5 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Not at all;Pilot repeat; n=5 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Moderately;Pilot repeat; n=5 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Minimally; Pilot repeat; n=5 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Not at all;Week12; n=15 | 15 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Moderately;Week12; n=15 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Minimally; Week12; n=15 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Not at all;Week24; n=14 | 12 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Moderately;Week24; n=14 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Minimally; Week24; n=14 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Not at all;Week36; n=14 | 12 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Moderately;Week36; n=14 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Minimally; Week36; n=14 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Not at all;Week48; n=18 | 15 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Moderately;Week48; n=18 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Minimally; Week48; n=18 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Not at all;EWD; n=2 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Moderately;EWD; n=2 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Impact on Sleep | Minimally; EWD; n=2 | 0 Participants |
Other Pre-specified
Number of Participants Reporting Sensor Comfort
Participant's feedback on whether the sensor was comfortable to wear was categorized as yes and no. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mega Faros Device + Fast Fix | Number of Participants Reporting Sensor Comfort | Sensor comfortable to wear;Pilot; n=5;Yes | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Sensor Comfort | Sensor comfortable to wear;Pilot; n=5;No | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Sensor Comfort | Sensor comfortable to wear;Pilot repeat; n=5;Yes | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Sensor Comfort | Sensor comfortable to wear;Pilot repeat; n=5;No | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Sensor Comfort | Sensor comfortable to wear;Week12; n=15;Yes | 14 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Sensor Comfort | Sensor comfortable to wear;Week12; n=15;No | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Sensor Comfort | Sensor comfortable to wear;Week24; n=14; Yes | 13 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Sensor Comfort | Sensor comfortable to wear;Week24; n=14;No | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Sensor Comfort | Sensor comfortable to wear;Week36; n=14; Yes | 12 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Sensor Comfort | Sensor comfortable to wear;Week36; n=14; No | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Sensor Comfort | Sensor comfortable to wear;Week48; n=18; Yes | 14 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Sensor Comfort | Sensor comfortable to wear;Week48; n=18;No | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Sensor Comfort | Sensor comfortable to wear;EWD; n=2;Yes | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Reporting Sensor Comfort | Sensor comfortable to wear;EWD; n=2;No | 2 Participants |
Other Pre-specified
Number of Participants Whose Sensor Fell Off
The participants reported whether the sensor fell off. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 12;No;n=20 | 19 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 16;Yes; n=18 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 16;No; n=18 | 18 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Pilot;Yes;n=5 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Pilot;No;n=5 | 5 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Pilot Repeat;Yes;n=5 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Pilot Repeat;No;n=5 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 0; Yes; n=25 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 0; No; n=25 | 25 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 4; Yes;n=23 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 4;No; n=23 | 21 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 8; Yes; n=21 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 8; No; n=21 | 17 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 12; Yes;n=20 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 20; Yes; n=20 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 20; No; n=20 | 19 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 24;Yes; n=18 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 24;No; n=18 | 16 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 28;Yes; n=16 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 28;No; n=16 | 15 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 32;Yes; n=20 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 32;No; n=20 | 19 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 36;Yes; n=18 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 36;No; n=18 | 18 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 40;Yes; n=15 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 40;No; n=15 | 14 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 44;Yes; n=16 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 44;No; n=16 | 16 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 48;Yes; n=15 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants Whose Sensor Fell Off | Week 48;No; n=15 | 15 Participants |
Other Pre-specified
Number of Participants With Adverse Events Secondary to the Devices Used or Due to Study Procedures
Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE.
Time frame: Up to Week 48
Population: Safety Population comprised of all participants who carried out at least one protocol specified procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mega Faros Device + Fast Fix | Number of Participants With Adverse Events Secondary to the Devices Used or Due to Study Procedures | AEs | 6 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Adverse Events Secondary to the Devices Used or Due to Study Procedures | SAEs | 0 Participants |
Other Pre-specified
Number of Participants With Corresponding Activity Level Required to Complete Their Job
The activity level required by the participant to complete their job was recorded, and was categorized as Not working, Physical activity required, and Sedentary. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week44; Sedentary;n=16 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week48; Not working;n=15 | 7 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week48; Physical activity required;n=15 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week48; Sedentary;n=15 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Pilot; Not working;n=5 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Pilot; Physical activity required;n=5 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Pilot; Sedentary;n=5 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Pilot repeat; Not working;n=5 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Pilot Repeat; Physical activity required;n=5 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Pilot Repeat; Sedentary;n=5 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week0; Not working;n=25 | 10 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week0; Physical activity required;n=25 | 10 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week0; Sedentary;n=25 | 5 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week4; Not working;n=23 | 8 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week4; Physical activity required;n=23 | 7 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week4; Sedentary;n=23 | 8 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week8; Not working;n=21 | 12 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week8; Physical activity required;n=21 | 5 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week8; Sedentary;n=21 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week12; Not working;n=20 | 8 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week12; Physical activity required;n=20 | 5 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week12; Sedentary;n=20 | 7 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week16; Not working;n=18 | 11 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week16; Physical activity required;n=18 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week16; Sedentary;n=18 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week20; Not working;n=20 | 11 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week20; Physical activity required;n=20 | 5 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week20; Sedentary;n=20 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week24; Not working;n=18 | 11 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week24; Physical activity required;n=18 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week24; Sedentary;n=18 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week28; Not working;n=16 | 9 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week28; Physical activity required;n=16 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week28; Sedentary;n=16 | 5 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week32; Not working;n=20 | 11 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week32; Physical activity required;n=20 | 5 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week32; Sedentary;n=20 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week36; Not working;n=18 | 11 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week36; Physical activity required;n=18 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week36; Sedentary;n=18 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week40; Not working;n=15 | 7 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week40; Physical activity required;n=15 | 7 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week40; Sedentary;n=15 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week44; Not working;n=16 | 8 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Activity Level Required to Complete Their Job | Week44; Physical activity required;n=16 | 4 Participants |
Other Pre-specified
Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor
Average activity level during the time of wearing the sensor was reported by the participants, and was categorized as very low level activity, low level activity, moderate level activity and high level activity. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Pilot;Very low level activity;n=5 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Pilot; Low level activity; n=5 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Pilot;Moderate level activity;n=5 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Pilot;High level activity;n=5 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Pilot repeat;Very low level activity;n=5 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Pilot repeat; Low level activity; n=5 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Pilot repeat;Moderate level activity;n=5 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Pilot repeat;High level activity;n=5 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week0;Very low level activity;n=25 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week0;Low level activity;n=25 | 6 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week0;Moderate level activity;n=25 | 14 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week0;High level activity;n=25 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week4;Very low level activity;n=23 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week4;Low level activity;n=23 | 9 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week4;Moderate level activity;n=23 | 11 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week4;High level activity;n=23 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week8;Very low level activity;n=21 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week8;Low level activity;n=21 | 11 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week8;Moderate level activity;n=21 | 9 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week8;High level activity;n=21 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week12;Very low level activity;n=20 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week12;Low level activity;n=20 | 11 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week12;Moderate level activity;n=20 | 6 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week12;High level activity;n=20 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week16;Very low level activity;n=18 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week16;Low level activity;n=18 | 9 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week16;Moderate level activity;n=18 | 8 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week16;High level activity;n=18 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week20;Very low level activity;n=20 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week20;Low level activity;n=20 | 14 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week20;Moderate level activity;n=20 | 5 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week20;High level activity;n=20 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week24;Very low level activity;n=18 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week24;Low level activity;n=18 | 10 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week24;Moderate level activity;n=18 | 7 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week24;High level activity;n=18 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week28;Very low level activity;n=16 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week28;Low level activity;n=16 | 10 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week28;Moderate level activity;n=16 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week28;High level activity;n=16 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week32;Very low level activity;n=20 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week32;Low level activity;n=20 | 10 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week32;Moderate level activity;n=20 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week32;High level activity;n=20 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week36;Very low level activity;n=18 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week36;Low level activity;n=18 | 9 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week36;Moderate level activity;n=18 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week36;High level activity;n=18 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week40;Very low level activity;n=15 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week40;Low level activity;n=15 | 7 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week40;Moderate level activity;n=15 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week40;High level activity;n=15 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week44;Very low level activity;n=16 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week44;Low level activity;n=16 | 8 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week44;Moderate level activity;n=16 | 6 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week44;High level activity;n=16 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week48;Very low level activity;n=15 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week48;Low level activity;n=15 | 7 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week48;Moderate level activity;n=15 | 5 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Week48;High level activity;n=15 | 1 Participants |
Other Pre-specified
Number of Participants With Ease of Setting up and Attaching the Sensor
The participants were required to give feedback on how easy was it to set up and/ or attach the sensor and it was categorized as easy, neutral and difficult. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Difficult;Week20; n=20 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Easy;Week24; n=18 | 15 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Easy;Pilot; n=5 | 4 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Neutral;Pilot; n=5 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Difficult;Pilot; n=5 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Easy;Pilot repeat; n=5 | 5 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Neutral;Pilot repeat; n=5 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Difficult;Pilot repeat; n=5 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Easy;Week0; n=25 | 23 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Neutral;Week0; n=25 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Difficult;Week0; n=25 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Easy;Week4; n=23 | 23 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Neutral;Week4; n=23 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Neutral;Week24; n=18 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Difficult;Week4; n=23 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Easy;Week8; n=21 | 19 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Neutral;Week8; n=21 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Difficult;Week24; n=18 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Easy;Week28; n=16 | 12 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Neutral;Week28; n=16 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Difficult;Week8; n=21 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Difficult;Week28; n=16 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Easy;Week12; n=20 | 18 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Neutral;Week12; n=20 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Easy;Week32; n=20 | 15 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Neutral;Week32; n=20 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Difficult;Week32; n=20 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Easy;Week36; n=18 | 14 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Neutral;Week36; n=18 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Difficult;Week12; n=20 | 0 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Easy;Week16; n=18 | 15 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Neutral;Week16; n=18 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Difficult;Week16; n=18 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Easy;Week20; n=20 | 15 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Neutral;Week20; n=20 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Difficult;Week36; n=18 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Easy;Week40; n=15 | 10 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Neutral;Week40; n=15 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Difficult;Week40; n=15 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Easy;Week44; n=16 | 13 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Neutral;Week44; n=16 | 1 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Difficult;Week44; n=16 | 2 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Easy;Week48; n=15 | 8 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Neutral;Week48; n=15 | 3 Participants |
| Mega Faros Device + Fast Fix | Number of Participants With Ease of Setting up and Attaching the Sensor | Difficult;Week48; n=15 | 4 Participants |
Other Pre-specified
Percentage Pause Time
Percentage pause time for running speech was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Percentage Pause Time | Week0; n=25 | 31.900 Percentage of time | Standard Deviation 17.1724 |
| Mega Faros Device + Fast Fix | Percentage Pause Time | Week12; n=18 | 26.609 Percentage of time | Standard Deviation 8.1333 |
| Mega Faros Device + Fast Fix | Percentage Pause Time | Week24; n=17 | 30.177 Percentage of time | Standard Deviation 14.3137 |
| Mega Faros Device + Fast Fix | Percentage Pause Time | Week36; n=15 | 24.410 Percentage of time | Standard Deviation 9.5753 |
| Mega Faros Device + Fast Fix | Percentage Pause Time | Week48; n=18 | 23.991 Percentage of time | Standard Deviation 11.8426 |
| Mega Faros Device + Fast Fix | Percentage Pause Time | EWD; n=2 | 24.042 Percentage of time | Standard Deviation 0.3466 |
Other Pre-specified
Percent of Time Lying Down at Night
Percent time spent lying per day and night over the 24-hour recording periods; averaged for each timepoint
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Night time, Week 20, n=13 | 97.739 Percentage of time | Standard Deviation 1.1617 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Day time, Week 0, n=24 | 12.079 Percentage of time | Standard Deviation 8.3771 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Day time, Week 4, n=22 | 14.119 Percentage of time | Standard Deviation 13.834 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Day time, Week 8, n=18 | 17.993 Percentage of time | Standard Deviation 12.7684 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Day time, Week 12, n=16 | 13.101 Percentage of time | Standard Deviation 9.7891 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Day time, Week 16, n=13 | 12.400 Percentage of time | Standard Deviation 9.3903 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Day time, Week 20, n=14 | 21.198 Percentage of time | Standard Deviation 25.9982 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Day time, Week 24, n=14 | 23.608 Percentage of time | Standard Deviation 28.1925 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Day time, Week 28, n=10 | 23.603 Percentage of time | Standard Deviation 23.9283 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Day time, Week 32, n=12 | 26.613 Percentage of time | Standard Deviation 34.2248 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Day time, Week 36, n=12 | 21.823 Percentage of time | Standard Deviation 28.2251 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Day time, Week 40, n=12 | 17.453 Percentage of time | Standard Deviation 19.6178 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Day time, Week 44, n=12 | 20.397 Percentage of time | Standard Deviation 26.7615 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Day time, Week 48, n=13 | 20.966 Percentage of time | Standard Deviation 20.3006 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Night time, Week 0, n=24 | 95.131 Percentage of time | Standard Deviation 8.2933 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Night time, Week 4, n=22 | 97.280 Percentage of time | Standard Deviation 2.9257 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Night time, Week 8, n=19 | 96.871 Percentage of time | Standard Deviation 4.0262 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Night time, Week 12, n=16 | 97.886 Percentage of time | Standard Deviation 1.4457 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Night time, Week 16, n=13 | 97.817 Percentage of time | Standard Deviation 1.1466 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Night time, Week 24, n=14 | 97.522 Percentage of time | Standard Deviation 1.6446 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Night time, Week 28, n=10 | 96.397 Percentage of time | Standard Deviation 2.1777 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Night time, Week 32, n=12 | 95.519 Percentage of time | Standard Deviation 6.0885 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Night time, Week 36, n=10 | 98.165 Percentage of time | Standard Deviation 0.6796 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Night time, Week 40, n=12 | 97.293 Percentage of time | Standard Deviation 1.8971 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Night time, Week 44, n=11 | 97.719 Percentage of time | Standard Deviation 1.6543 |
| Mega Faros Device + Fast Fix | Percent of Time Lying Down at Night | Night time, Week 48, n=13 | 93.912 Percentage of time | Standard Deviation 14.0863 |
Other Pre-specified
Percent Time Night-time Rest Efficiency
Average night-time rest efficiency for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Percent Time Night-time Rest Efficiency | Week 44, n=11 | 0.992 Percentage of time | Standard Deviation 0.004 |
| Mega Faros Device + Fast Fix | Percent Time Night-time Rest Efficiency | Week 0, n=24 | 0.986 Percentage of time | Standard Deviation 0.0125 |
| Mega Faros Device + Fast Fix | Percent Time Night-time Rest Efficiency | Week 4, n=22 | 0.982 Percentage of time | Standard Deviation 0.027 |
| Mega Faros Device + Fast Fix | Percent Time Night-time Rest Efficiency | Week 8, n=19 | 0.976 Percentage of time | Standard Deviation 0.0498 |
| Mega Faros Device + Fast Fix | Percent Time Night-time Rest Efficiency | Week 12, n=16 | 0.991 Percentage of time | Standard Deviation 0.0044 |
| Mega Faros Device + Fast Fix | Percent Time Night-time Rest Efficiency | Week 16, n=13 | 0.986 Percentage of time | Standard Deviation 0.0156 |
| Mega Faros Device + Fast Fix | Percent Time Night-time Rest Efficiency | Week 20, n=13 | 0.987 Percentage of time | Standard Deviation 0.0118 |
| Mega Faros Device + Fast Fix | Percent Time Night-time Rest Efficiency | Week 24, n=14 | 0.991 Percentage of time | Standard Deviation 0.0053 |
| Mega Faros Device + Fast Fix | Percent Time Night-time Rest Efficiency | Week 28, n=10 | 0.986 Percentage of time | Standard Deviation 0.0165 |
| Mega Faros Device + Fast Fix | Percent Time Night-time Rest Efficiency | Week 32, n=12 | 0.978 Percentage of time | Standard Deviation 0.0322 |
| Mega Faros Device + Fast Fix | Percent Time Night-time Rest Efficiency | Week 36, n=10 | 0.971 Percentage of time | Standard Deviation 0.0468 |
| Mega Faros Device + Fast Fix | Percent Time Night-time Rest Efficiency | Week 40, n=12 | 0.987 Percentage of time | Standard Deviation 0.0156 |
| Mega Faros Device + Fast Fix | Percent Time Night-time Rest Efficiency | Week 48, n=13 | 0.978 Percentage of time | Standard Deviation 0.0536 |
Other Pre-specified
Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R
Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that sample size was insufficient to calculate correlation coefficient
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R | Mean HRV effect of being upright v/s ALSFRS-R;n=24 | 0.139 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R | Mean LF/HF (lying down) (1) v/s ALSFRS-R;n=25 | 0.228 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R | Mean LF/HF sedentary (not lying) v/s ALSFRS-R;n=24 | 0.023 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R | Var. LF/HF sedentary (not lying) v/s ALSFR-R;n=24 | -0.041 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R | Mean HRV effect of activity v/s ALSFRS-R;n=3 | 0.421 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R | Mean LF/HF (avg-daytime activity) v/s ALSFRS-R;n=3 | -0.921 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R | Var of HRV effect of activity v/s ALSFRS-R;n=3 | 0.419 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R | Var of HRV effect being upright v/s ALSFRS-R;n=24 | 0.308 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R | Var of LF/HF (lying down) v/s ALSFRS-R;n=25 | -0.378 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R | Var of LF/HF v/s ALSFRS-R;n=3 | NA Ratio |
Other Pre-specified
Relationship Between Absolute Values of Speech Endpoints and Absolute Value of ALSFRS-R
Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Repeated Measures Correlation Coefficient has been presented in the table below
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of Speech Endpoints and Absolute Value of ALSFRS-R | Jitter (%) (Short ah) v/s ALSFRS-R | 0.137 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of Speech Endpoints and Absolute Value of ALSFRS-R | CTF F0 (Long ah) v/s ALSFRS-R | -0.154 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of Speech Endpoints and Absolute Value of ALSFRS-R | Jitter (%) (Long ah) v/s ALSFRS-R | 0.119 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of Speech Endpoints and Absolute Value of ALSFRS-R | Shimmer(%) (Long ah) v/s ALSFRS-R | 0.138 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of Speech Endpoints and Absolute Value of ALSFRS-R | Maximum Phonation Time v/s ALSFRS-R | 0.152 Ratio |
Other Pre-specified
Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC
Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Between Subject Correlation Coefficient has been presented in the table below
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC | CTF F0 (Short ah) v/s FVC | -0.214 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC | Jitter (%) (Short ah) v/s FVC | 0.143 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC | Shimmer(%) (Short ah) v/s FVC | -0.080 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC | CTF F0 (Long ah) v/s FVC | -0.504 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC | Jitter (%) (Long ah) v/s FVC | -0.321 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC | Shimmer(%) (Long ah) v/s FVC | -0.327 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC | Average Phoneme Rate v/s FVC | 0.453 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC | Maximum Phonation Time v/s FVC | -0.215 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC | Percent Pause Time v/s FVC | -0.376 Ratio |
| Mega Faros Device + Fast Fix | Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC | Speaking Rate v/s FVC | 0.547 Ratio |
Other Pre-specified
Relationship Between Average Duration Movement Episodes at Night Versus Total ALSFRS-R
Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mega Faros Device + Fast Fix | Relationship Between Average Duration Movement Episodes at Night Versus Total ALSFRS-R | -0.426 Ratio |
Other Pre-specified
Relationship Between Average Night Time Rest Fragmentation Index Versus Total ALSFRS-R
Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mega Faros Device + Fast Fix | Relationship Between Average Night Time Rest Fragmentation Index Versus Total ALSFRS-R | -0.163 Ratio |
Other Pre-specified
Relationship Between Average Number Night Time Movements/Hour Versus Total ALSFRS-R
Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mega Faros Device + Fast Fix | Relationship Between Average Number Night Time Movements/Hour Versus Total ALSFRS-R | 0.178 Ratio |
Other Pre-specified
Relationship Between Average Percent Time Night Time Rest Efficiency Versus Total ALSFRS-R
Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mega Faros Device + Fast Fix | Relationship Between Average Percent Time Night Time Rest Efficiency Versus Total ALSFRS-R | 0.049 Ratio |
Other Pre-specified
Rest Fragmentation Index
Rest Fragmentation Index was computed as movement time (%) divided by number of movement episodes for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Rest Fragmentation Index | Week 0, n=24 | 0.132 Ratio | Standard Deviation 0.3384 |
| Mega Faros Device + Fast Fix | Rest Fragmentation Index | Week 4, n=22 | 0.649 Ratio | Standard Deviation 2.6064 |
| Mega Faros Device + Fast Fix | Rest Fragmentation Index | Week 8, n=19 | 0.096 Ratio | Standard Deviation 0.2579 |
| Mega Faros Device + Fast Fix | Rest Fragmentation Index | Week 12, n=16 | 0.036 Ratio | Standard Deviation 0.0316 |
| Mega Faros Device + Fast Fix | Rest Fragmentation Index | Week 16, n=13 | 0.291 Ratio | Standard Deviation 0.8315 |
| Mega Faros Device + Fast Fix | Rest Fragmentation Index | Week 20, n=13 | 0.086 Ratio | Standard Deviation 0.1581 |
| Mega Faros Device + Fast Fix | Rest Fragmentation Index | Week 24, n=14 | 0.129 Ratio | Standard Deviation 0.3213 |
| Mega Faros Device + Fast Fix | Rest Fragmentation Index | Week 28, n=10 | 0.113 Ratio | Standard Deviation 0.2836 |
| Mega Faros Device + Fast Fix | Rest Fragmentation Index | Week 32, n=12 | 0.507 Ratio | Standard Deviation 1.1908 |
| Mega Faros Device + Fast Fix | Rest Fragmentation Index | Week 36, n=10 | 0.437 Ratio | Standard Deviation 1.1594 |
| Mega Faros Device + Fast Fix | Rest Fragmentation Index | Week 40, n=12 | 0.541 Ratio | Standard Deviation 1.707 |
| Mega Faros Device + Fast Fix | Rest Fragmentation Index | Week 44, n=11 | 0.041 Ratio | Standard Deviation 0.0259 |
| Mega Faros Device + Fast Fix | Rest Fragmentation Index | Week 48, n=13 | 0.391 Ratio | Standard Deviation 1.2979 |
Other Pre-specified
Speaking Rate
Speaking rate was analyzed during running speech. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Speaking Rate | Week0; n=25 | 151.490 Words per minute | Standard Deviation 42.3137 |
| Mega Faros Device + Fast Fix | Speaking Rate | Week12; n=18 | 160.628 Words per minute | Standard Deviation 46.2482 |
| Mega Faros Device + Fast Fix | Speaking Rate | Week24; n=17 | 153.958 Words per minute | Standard Deviation 45.2931 |
| Mega Faros Device + Fast Fix | Speaking Rate | Week36; n=15 | 166.342 Words per minute | Standard Deviation 67.6138 |
| Mega Faros Device + Fast Fix | Speaking Rate | Week48; n=18 | 138.984 Words per minute | Standard Deviation 65.6871 |
| Mega Faros Device + Fast Fix | Speaking Rate | EWD; n=2 | 179.687 Words per minute | Standard Deviation 27.6064 |
Other Pre-specified
Time Spent With Sensor Off
Sensor off time includes the time that the sensor was either switched off or the participant was not wearing it (or both). This outcome measure was planned but not performed.
Time frame: Up to Week 48
Population: Full Analysis Set
Other Pre-specified
Total Activity Count
Total activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Total Activity Count | Day time, Week 0, n=24 | 3336.550 Count of activity | Standard Deviation 2654.406 |
| Mega Faros Device + Fast Fix | Total Activity Count | Day time, Week 4, n=22 | 2903.633 Count of activity | Standard Deviation 3059.2 |
| Mega Faros Device + Fast Fix | Total Activity Count | Day time, Week 8, n=17 | 4244.521 Count of activity | Standard Deviation 6314.828 |
| Mega Faros Device + Fast Fix | Total Activity Count | Day time, Week 12, n=16 | 2076.129 Count of activity | Standard Deviation 1338.276 |
| Mega Faros Device + Fast Fix | Total Activity Count | Day time, Week 16, n=13 | 2216.162 Count of activity | Standard Deviation 1732.185 |
| Mega Faros Device + Fast Fix | Total Activity Count | Day time, Week 20, n=14 | 1858.116 Count of activity | Standard Deviation 1504.067 |
| Mega Faros Device + Fast Fix | Total Activity Count | Day time, Week 24, n=13 | 1114.152 Count of activity | Standard Deviation 683.2223 |
| Mega Faros Device + Fast Fix | Total Activity Count | Day time, Week 28, n=10 | 1468.741 Count of activity | Standard Deviation 1559.431 |
| Mega Faros Device + Fast Fix | Total Activity Count | Day time, Week 32, n=12 | 1247.969 Count of activity | Standard Deviation 1015.319 |
| Mega Faros Device + Fast Fix | Total Activity Count | Day time, Week 36, n=12 | 1675.754 Count of activity | Standard Deviation 1979.21 |
| Mega Faros Device + Fast Fix | Total Activity Count | Day time, Week 40, n=12 | 1542.138 Count of activity | Standard Deviation 1421.696 |
| Mega Faros Device + Fast Fix | Total Activity Count | Day time, Week 44, n=12 | 2252.325 Count of activity | Standard Deviation 1923.793 |
| Mega Faros Device + Fast Fix | Total Activity Count | Day time, Week 48, n=13 | 1972.506 Count of activity | Standard Deviation 2209.802 |
| Mega Faros Device + Fast Fix | Total Activity Count | Night time, Week 0, n=24 | 357.865 Count of activity | Standard Deviation 293.7938 |
| Mega Faros Device + Fast Fix | Total Activity Count | Night time, Week 4, n=22 | 265.096 Count of activity | Standard Deviation 102.7897 |
| Mega Faros Device + Fast Fix | Total Activity Count | Night time, Week 8, n=13 | 652.108 Count of activity | Standard Deviation 1445.624 |
| Mega Faros Device + Fast Fix | Total Activity Count | Night time, Week 12, n=16 | 234.854 Count of activity | Standard Deviation 68.8019 |
| Mega Faros Device + Fast Fix | Total Activity Count | Night time, Week 16, n=13 | 254.238 Count of activity | Standard Deviation 46.4883 |
| Mega Faros Device + Fast Fix | Total Activity Count | Night time, Week 20, n=14 | 241.504 Count of activity | Standard Deviation 68.9048 |
| Mega Faros Device + Fast Fix | Total Activity Count | Night time, Week 24, n=14 | 249.504 Count of activity | Standard Deviation 165.5673 |
| Mega Faros Device + Fast Fix | Total Activity Count | Night time, Week 28, n=10 | 328.374 Count of activity | Standard Deviation 222.3131 |
| Mega Faros Device + Fast Fix | Total Activity Count | Night time, Week 32, n=12 | 271.988 Count of activity | Standard Deviation 189.5221 |
| Mega Faros Device + Fast Fix | Total Activity Count | Night time, Week 36, n=10 | 211.270 Count of activity | Standard Deviation 101.457 |
| Mega Faros Device + Fast Fix | Total Activity Count | Night time, Week 40, n=12 | 212.134 Count of activity | Standard Deviation 68.5433 |
| Mega Faros Device + Fast Fix | Total Activity Count | Night time, Week 44, n=11 | 232.571 Count of activity | Standard Deviation 117.191 |
| Mega Faros Device + Fast Fix | Total Activity Count | Night time, Week 48, n=13 | 224.375 Count of activity | Standard Deviation 110.9312 |
Other Pre-specified
Type of Adverse Events Secondary to the Devices Used or Due to Study Procedures
Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Number of AEs, SAEs and Adverse events leading to discontinuation (AELDs)from the study is presented
Time frame: Up to Week 48
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mega Faros Device + Fast Fix | Type of Adverse Events Secondary to the Devices Used or Due to Study Procedures | AEs | 6 Events |
| Mega Faros Device + Fast Fix | Type of Adverse Events Secondary to the Devices Used or Due to Study Procedures | SAEs | 0 Events |
Other Pre-specified
Variance of HRV While Active (LF/HF)
Variance of Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Variance of HRV While Active (LF/HF) | Week 0, n=2 | 0.0000 Ratio | Standard Deviation 0 |
| Mega Faros Device + Fast Fix | Variance of HRV While Active (LF/HF) | Week 4, n=1 | 0.0000 Ratio | — |
Other Pre-specified
Variance of HRV While Lying (LF/HF)
Variance of Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Variance of HRV While Lying (LF/HF) | Week 0, n=23 | 6.3439 Ratio | Standard Deviation 6.55782 |
| Mega Faros Device + Fast Fix | Variance of HRV While Lying (LF/HF) | Week 4, n=21 | 6.8401 Ratio | Standard Deviation 6.49766 |
| Mega Faros Device + Fast Fix | Variance of HRV While Lying (LF/HF) | Week 8, n=15 | 5.3481 Ratio | Standard Deviation 4.86394 |
| Mega Faros Device + Fast Fix | Variance of HRV While Lying (LF/HF) | Week 12, n=15 | 11.4190 Ratio | Standard Deviation 11.42238 |
| Mega Faros Device + Fast Fix | Variance of HRV While Lying (LF/HF) | Week 16, n=12 | 16.1974 Ratio | Standard Deviation 20.59606 |
| Mega Faros Device + Fast Fix | Variance of HRV While Lying (LF/HF) | Week 20, n=12 | 10.2248 Ratio | Standard Deviation 13.69276 |
| Mega Faros Device + Fast Fix | Variance of HRV While Lying (LF/HF) | Week 24, n=12 | 6.5774 Ratio | Standard Deviation 9.07676 |
| Mega Faros Device + Fast Fix | Variance of HRV While Lying (LF/HF) | Week 28, n=10 | 6.6424 Ratio | Standard Deviation 7.53794 |
| Mega Faros Device + Fast Fix | Variance of HRV While Lying (LF/HF) | Week 32, n=10 | 5.8556 Ratio | Standard Deviation 7.19624 |
| Mega Faros Device + Fast Fix | Variance of HRV While Lying (LF/HF) | Week 36, n=9 | 15.4940 Ratio | Standard Deviation 30.00587 |
| Mega Faros Device + Fast Fix | Variance of HRV While Lying (LF/HF) | Week 40, n=11 | 4.5088 Ratio | Standard Deviation 3.5672 |
| Mega Faros Device + Fast Fix | Variance of HRV While Lying (LF/HF) | Week 44, n=11 | 6.4731 Ratio | Standard Deviation 6.29614 |
| Mega Faros Device + Fast Fix | Variance of HRV While Lying (LF/HF) | Week 48, n=11 | 11.7375 Ratio | Standard Deviation 13.64105 |
Other Pre-specified
Variance of HRV While Sedentary Not Lying (LF/HF)
Variance of Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mega Faros Device + Fast Fix | Variance of HRV While Sedentary Not Lying (LF/HF) | Week 0, n=20 | 6.3439 Ratio | Standard Deviation 6.55782 |
| Mega Faros Device + Fast Fix | Variance of HRV While Sedentary Not Lying (LF/HF) | Week 4, n=18 | 6.8401 Ratio | Standard Deviation 6.49766 |
| Mega Faros Device + Fast Fix | Variance of HRV While Sedentary Not Lying (LF/HF) | Week 8, n=13 | 5.3481 Ratio | Standard Deviation 4.86394 |
| Mega Faros Device + Fast Fix | Variance of HRV While Sedentary Not Lying (LF/HF) | Week 12, n=14 | 11.4190 Ratio | Standard Deviation 11.42238 |
| Mega Faros Device + Fast Fix | Variance of HRV While Sedentary Not Lying (LF/HF) | Week 16, n=11 | 16.1974 Ratio | Standard Deviation 20.59606 |
| Mega Faros Device + Fast Fix | Variance of HRV While Sedentary Not Lying (LF/HF) | Week 20, n=10 | 10.2248 Ratio | Standard Deviation 13.69276 |
| Mega Faros Device + Fast Fix | Variance of HRV While Sedentary Not Lying (LF/HF) | Week 24, n=10 | 6.5774 Ratio | Standard Deviation 9.07676 |
| Mega Faros Device + Fast Fix | Variance of HRV While Sedentary Not Lying (LF/HF) | Week 28, n=9 | 6.6424 Ratio | Standard Deviation 7.53794 |
| Mega Faros Device + Fast Fix | Variance of HRV While Sedentary Not Lying (LF/HF) | Week 32, n=9 | 5.8556 Ratio | Standard Deviation 7.19624 |
| Mega Faros Device + Fast Fix | Variance of HRV While Sedentary Not Lying (LF/HF) | Week 36, n=11 | 15.4940 Ratio | Standard Deviation 30.00587 |
| Mega Faros Device + Fast Fix | Variance of HRV While Sedentary Not Lying (LF/HF) | Week 40, n=9 | 4.5088 Ratio | Standard Deviation 3.5672 |
| Mega Faros Device + Fast Fix | Variance of HRV While Sedentary Not Lying (LF/HF) | Week 44, n=9 | 6.4731 Ratio | Standard Deviation 6.29614 |
| Mega Faros Device + Fast Fix | Variance of HRV While Sedentary Not Lying (LF/HF) | Week 48, n=7 | 11.7375 Ratio | Standard Deviation 13.64105 |