Sleep Apnea, Sleep-Disordered Breathing
Conditions
Brief summary
The objective of this study is to test the usability of the Alice PDx device by both the end user (patient/participant) and the sleep technician. Data will be collected via questionnaires regarding the participant's ability to understand the participant user manual under home conditions and the technician's ability to set up the Alice PDx according to the health care provider manual. This study will also compare the physiological data recorded by the Alice PDx to the physiological data recorded by its predicate device the Alice 5 System and validate its equivalence. This will be evaluated by comparing the manual study scores for detected apnea and hypopnea events and on an event by event basis during a standard polysomnography (PSG)/ sleep study. The study will test the ability of the Alice PDx to record good quality data as determined by the Good Study Indicator (GSI) function of the Alice PDx firmware. The primary hypothesis is that the participant will be able to successfully apply the Alice PDx basic leads following the participant user manual instructions and the sleep technician will be able to successfully apply the advanced leads in preparation for the sleep study. In addition, it will be demonstrated that the Alice PDx is equivalent to the Alice 5 System in its intent to record, display and print physiological data to the clinician/physician in order to aid in the screening/follow-up diagnosis of respiratory sleep disorders.
Detailed description
Alice PDx is a portable, diagnostic recording device. It may be used for obstructive sleep screening as well as follow-up and diagnostic assessment. The device may be used in a sleep lab or clinical setting by trained professionals and it may be used at home by patients as directed by their health care provider. The Alice PDx device is not currently approved by the Food and Drug Administration (FDA). The Alice PDx device is capable of recording various physiological inputs and storing the data locally on a removable storage card. The device may also be connected directly to a PC (personal computer) running the Alice Sleepware software application. Sleepware can display live or pre-recorded data in a resolution consistent with the computer hardware specifications.
Interventions
DEVICEAlice PDx with only written instructions
Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed.
DEVICEAlice PDx with written and verbal instructions
Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed.
Sponsors
Philips Respironics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must call into a sleep lab or be referred to a sleep lab for a diagnostic polysomnogram * Able to follow directions * Able to provide informed consent
Exclusion criteria
* Participants requiring supplemental oxygen therapy * History of having a previous sleep study/polysomnogram performed * Current positive airway pressure (PAP) users * Unable or unwilling to perform a polysomnogram
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| This Study Will Compare the Apnea Hypopnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Lab Night | The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI detected events of Alice 5 system was compared to the AHI events of the Alice PDx. |
| This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Lab Night | The central apnea index, hypopnea index, mixed apnea index and obstructive apnea indexes are all values that are calculated by determining the type of apneic event (apnea, hypopnea, mixed or obstructive). Each type of event is added up over the night and divided by the number of hours. For this analysis each index was compared between both devices. |
| This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Lab Night | This study will compare different measurements recorded which include Time in Bed, Stage N1, Stage N2, Stage N3, REM, Sleep Onset Latency, Total Sleep Time, Wake Time in Bed and Wake After Sleep Onset by the Alice PDx to the measurement data recorded by its predicate device the Alice 5 System and validate its equivalence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Secondary Objective of This Study is to Compare the Measurements of the Alice PDx When Patients Complete the Set-up of the Device at Home and When Patients Are Set up by a Sleep Technician in the Sleep Laboratory. | Lab Night | The Alice PDx incorporates a unique Good Study Indicator (GSI). The GSI is a predicated on airflow and oximeter signal quality and displays the amount of good quality data needed for a study to be complete and valid. The GSI visually displays the amount of good quality data in 25-percent increments on the Alice PDx screen. For purposes of this secondary objective this number was compared from participants who set-up and wore the device at home and those that wore the device in a sleep lab set up by a sleep technician. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alice PDx With Only Written Instructions Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed. | 18 |
| Alice PDx With Written and Verbal Instructions Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.
Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed. | 14 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Alice PDx With Only Written Instructions | Alice PDx With Written and Verbal Instructions | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 14 Participants | 30 Participants |
| Body Mass Index | 35.4 kg/m^2 STANDARD_DEVIATION 8.8 | 32.6 kg/m^2 STANDARD_DEVIATION 6.6 | 34.2 kg/m^2 STANDARD_DEVIATION 7.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 14 Participants | 29 Participants |
| Region of Enrollment United States | 18 participants | 14 participants | 32 participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Male | 11 Participants | 5 Participants | 16 Participants |
| Smoking Status Non-Smokers | 16 participants | 9 participants | 23 participants |
| Smoking Status Smokers | 2 participants | 5 participants | 7 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 14 |
| other Total, other adverse events | 1 / 18 | 0 / 14 |
| serious Total, serious adverse events | 0 / 18 | 0 / 14 |
Outcome results
Primary
This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
This study will compare different measurements recorded which include Time in Bed, Stage N1, Stage N2, Stage N3, REM, Sleep Onset Latency, Total Sleep Time, Wake Time in Bed and Wake After Sleep Onset by the Alice PDx to the measurement data recorded by its predicate device the Alice 5 System and validate its equivalence.
Time frame: Lab Night
Population: All participants that completed the overnight portion of the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alice 5 System | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Time spent in Stage N1 | 5.82 minutes | Standard Deviation 4.25 |
| Alice 5 System | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Sleep Onset Latency | 16.98 minutes | Standard Deviation 15.39 |
| Alice 5 System | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Time spent in Stage N3 | 13.03 minutes | Standard Deviation 8.61 |
| Alice 5 System | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Total Sleep Time | 319.88 minutes | Standard Deviation 54.55 |
| Alice 5 System | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Time spent in Stage N2 | 52.50 minutes | Standard Deviation 13.51 |
| Alice 5 System | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Wake Time in Bed | 16.49 minutes | Standard Deviation 12.24 |
| Alice 5 System | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Time spent in Rapid Eye Movement (REM) | 12.14 minutes | Standard Deviation 6.88 |
| Alice 5 System | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Wake After Sleep Onset | 50.57 minutes | Standard Deviation 46.5 |
| Alice 5 System | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Time In Bed | 308.61 minutes | Standard Deviation 385.32 |
| Alice PDx | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Wake After Sleep Onset | 55.70 minutes | Standard Deviation 46.09 |
| Alice PDx | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Time In Bed | 178.49 minutes | Standard Deviation 209.16 |
| Alice PDx | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Time spent in Stage N1 | 5.43 minutes | Standard Deviation 2.73 |
| Alice PDx | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Time spent in Stage N2 | 51.05 minutes | Standard Deviation 9.59 |
| Alice PDx | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Time spent in Stage N3 | 13.54 minutes | Standard Deviation 9.29 |
| Alice PDx | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Time spent in Rapid Eye Movement (REM) | 11.74 minutes | Standard Deviation 5.63 |
| Alice PDx | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Sleep Onset Latency | 16.83 minutes | Standard Deviation 14.35 |
| Alice PDx | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Total Sleep Time | 314.93 minutes | Standard Deviation 58.56 |
| Alice PDx | This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Wake Time in Bed | 18.23 minutes | Standard Deviation 12.04 |
Primary
This Study Will Compare the Apnea Hypopnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI detected events of Alice 5 system was compared to the AHI events of the Alice PDx.
Time frame: Lab Night
Population: All participants that completed the overnight portion of the study were analyzed, they each had an Alice 5 System night and an Alice PDx night.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alice 5 System | This Study Will Compare the Apnea Hypopnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | 13.16 events | Standard Deviation 24.69 |
| Alice PDx | This Study Will Compare the Apnea Hypopnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | 20.24 events | Standard Deviation 24.88 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Primary
This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.
The central apnea index, hypopnea index, mixed apnea index and obstructive apnea indexes are all values that are calculated by determining the type of apneic event (apnea, hypopnea, mixed or obstructive). Each type of event is added up over the night and divided by the number of hours. For this analysis each index was compared between both devices.
Time frame: Lab Night
Population: All participants that completed the overnight portion of the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alice 5 System | This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Central Apnea Index | .18 events/hour | Standard Deviation 0.42 |
| Alice 5 System | This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Hypopnea index | 6.91 events/hour | Standard Deviation 8.33 |
| Alice 5 System | This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Mixed Apnea Index | .12 events/hour | Standard Deviation 0.38 |
| Alice 5 System | This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Obstructive Apnea Index | 5.95 events/hour | Standard Deviation 17.54 |
| Alice PDx | This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Obstructive Apnea Index | 11.97 events/hour | Standard Deviation 21.39 |
| Alice PDx | This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Central Apnea Index | .92 events/hour | Standard Deviation 2.64 |
| Alice PDx | This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Mixed Apnea Index | .21 events/hour | Standard Deviation 0.52 |
| Alice PDx | This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence. | Hypopnea index | 7.15 events/hour | Standard Deviation 4.8 |
Secondary
The Secondary Objective of This Study is to Compare the Measurements of the Alice PDx When Patients Complete the Set-up of the Device at Home and When Patients Are Set up by a Sleep Technician in the Sleep Laboratory.
The Alice PDx incorporates a unique Good Study Indicator (GSI). The GSI is a predicated on airflow and oximeter signal quality and displays the amount of good quality data needed for a study to be complete and valid. The GSI visually displays the amount of good quality data in 25-percent increments on the Alice PDx screen. For purposes of this secondary objective this number was compared from participants who set-up and wore the device at home and those that wore the device in a sleep lab set up by a sleep technician.
Time frame: Lab Night
Population: 3 participants were not able to provide usable GSI data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alice 5 System | The Secondary Objective of This Study is to Compare the Measurements of the Alice PDx When Patients Complete the Set-up of the Device at Home and When Patients Are Set up by a Sleep Technician in the Sleep Laboratory. | 88.9 percentage of average GSI | Standard Deviation 17.4 |
| Alice PDx | The Secondary Objective of This Study is to Compare the Measurements of the Alice PDx When Patients Complete the Set-up of the Device at Home and When Patients Are Set up by a Sleep Technician in the Sleep Laboratory. | 70.3 percentage of average GSI | Standard Deviation 31.1 |