Healthy Normals
Conditions
Brief summary
Study objective: The primary objective of the clinical investigation is to evaluate the accuracy of BioStamp nPoint system algorithm measurements. Study design: A single-site, non-significant risk, open-label, prospective non-randomized clinical investigation designed to validate the accuracy of the various physiological parameters that the Wearable Sensor Patches acquire and the system processes.
Interventions
DEVICEPhysiological signal monitor
Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.
DEVICEHeart rate and heart rate variability comparison device
FDA cleared reference device that monitors heart rate and heart rate variability in subjects
DEVICERespiration rate comparison device
FDA cleared reference device that monitors respiration rate in subjects
OTHERActivity classification
Visual annotation of subject posture and other activities used for reference
Sponsors
MC10 Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female volunteers, at least 18 years of age at the time of screening visit; 2. Fluent in English; 3. The subject is willing to comply with the protocol specified evaluations; 4. Subject is willing and cognitively able to sign informed consent
Exclusion criteria
1. Pregnancy; 2. Positive urine drug screen 3. History of active (clinically significant) skin disorders; 4. History of allergic response to silicones or adhesives; 5. Subjects with electronic implants of any kind (e.g. pacemaker) 6. History of sleep disorders or self-reported insomnia or other sleep conditions; 7. Broken, damaged or irritated skin or rashes near the sensor application sites; 8. Subjects that are MC10 employees or shareholders, or a spouse or child of an MC10 employee or shareholder; 9. Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device | 2 days after informed consent | Heart rate as measured by the subject device in beats per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented. |
| Accuracy of Heart Rate Variability Measured by Root Mean Square of Successive Differences (HRV RMSSD) Compared to the Reference Device | 2 days after informed consent | Heart Rate Variability RMSSD is measured by the subject device determined by root mean square of successive differences in neighboring RR intervals and will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented. |
| Accuracy of Heart Rate Variability Measured by Low Frequency Content to High Frequency Content Ratio (HRV Ratio) Compared to the Reference Device | 2 days after informed consent | HRV Ratio as measured by the subject device determined by low frequency content to high frequency content ratio (HRV Ratio) in beats per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented. |
| Accuracy of Respiration Rate Measured in Breaths Per Minute Compared to the Reference Device | 2 days after informed consent | Respiration rate as measured by the subject device in breaths per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented. |
| Accuracy of Activity Classification as Compared to Visual Annotation | 2 days after informed consent | The device under test will classify a subjects activity into sleeping, standing, sitting, lying, walking and other activities as the subject performs various predefined activities, which are annotated by an observer. The device's Activity Classification will be compared to the observer's annotation. The percentage of correct classifications by the device against indicated visual observation is presented. The percent correct is not a per subject average, but is the percentage of all activity classifications which were correct when compared to ground truth observation. |
| Accuracy of Step Count Compared to an Observer's Manual Count | 2 days after informed consent | The number of steps reported by the device under test during a 6 minute walk test will be compared to an observer's manual count of the number of steps taken. |
| Accuracy of Sleep Onset Time (Hours, Minutes, and Seconds), Sleep Wake Time (Hours, Minutes, and Seconds) as Compared to an Observer's Visual Annotation | 2 days after informed consent | Sleep onset and wake times as reported by the device under test will be compared to an observer's visual annotation of the sleep onset and wake times. The Mean Absolute Error (MAE) between times as indicated by the device and observed times is presented. |
| Accuracy of Posture Classification as Compared to Visual Annotation | 2 days after informed consent | The device under test will classify a subjects activity into sleep posture, standing posture, and sitting posture as the subject performs various predefined activities, which are annotated by an observer. The device's Posture Classification will be compared to the observer's annotation. The percentage of correct classifications by the device against indicated visual observation is presented. The percent correct is not a per subject average, but is the percentage of all posture classifications which were correct when compared to ground truth observation. |
| Number of Sensors That Remained Sufficiently Adhered to Subjects for 24 Hours as Assessed by a 5 Point Scale | 2 days after informed consent | The level of sensor adhesion will be assessed by a 5 point scale (0- sensor is greater than or equal to 90% of sensor adhered, 4-sensor completely detached from subject). Sensors receiving scores of 0 and 1 will be determined to have acceptable adhesion, while scores of 2, 3, and 4 will be considered unacceptable adhesion. The percentage of sensors which had acceptable adhesion at sensor removal is presented. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited via an established database at the clinical site, with the use of IRB approved flyers and posting on the clinical site website. The completely voluntary nature of participation in the study was emphasized. Subject recruitment and screening began July 17, 2017 and completed July 21, 2017.
Participants by arm
| Arm | Count |
|---|---|
| Device Monitoring This single arm consists of all subjects which will interact with the device under investigation as well as comparator devices.
This includes the Physiological signal monitor intervention, Heart rate and heart rate variability comparison device intervention, Respiration rate comparison device intervention, and Activity classification intervention.
Physiological signal monitor: Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.
Heart rate and heart rate variability comparison device: FDA cleared reference device that monitors heart rate and heart rate variability in subjects
Respiration rate comparison device: FDA cleared reference device that monitors respiration rate in subjects
Activity classification: Visual annotation of subject posture and other activities used for reference | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Device Monitoring | — |
|---|---|---|
| Age, Continuous | 35.9 years STANDARD_DEVIATION 10.1 | — |
| BMI | 28.12 kg/m^2 STANDARD_DEVIATION 3.57 | — |
| Height (cm) | 172.17 centimeters STANDARD_DEVIATION 8.61 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 23 Participants | — |
| Weight (kg) | 83.33 kilograms STANDARD_DEVIATION 11.63 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 1 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Accuracy of Activity Classification as Compared to Visual Annotation
The device under test will classify a subjects activity into sleeping, standing, sitting, lying, walking and other activities as the subject performs various predefined activities, which are annotated by an observer. The device's Activity Classification will be compared to the observer's annotation. The percentage of correct classifications by the device against indicated visual observation is presented. The percent correct is not a per subject average, but is the percentage of all activity classifications which were correct when compared to ground truth observation.
Time frame: 2 days after informed consent
Population: All subjects were analyzed, with classifications compared against n = 5 clinician observed one minute long activities (lying, sitting, standing, walking, and stationary biking for other classification) per subject. For analysis of sleep classification accuracy, n = 5 one minute long samples were sampled across both nights of sleep per subject.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Monitoring | Accuracy of Activity Classification as Compared to Visual Annotation | 98.7 percent correct |
Primary
Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device
Heart rate as measured by the subject device in beats per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.
Time frame: 2 days after informed consent
Population: Once comparator device malfunctioned resulting in a complete loss of Heart Rate data for one subject. All other subjects were analyzed, with n = 24 HR data pairs sampled at random (n = 8 samples each from sleeping, resting, and moving activities) per subject when available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Monitoring | Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device | 2.0 beats per minute | Standard Deviation 5.1 |
Primary
Accuracy of Heart Rate Variability Measured by Low Frequency Content to High Frequency Content Ratio (HRV Ratio) Compared to the Reference Device
HRV Ratio as measured by the subject device determined by low frequency content to high frequency content ratio (HRV Ratio) in beats per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.
Time frame: 2 days after informed consent
Population: One comparator device malfunctioned, resulting in a complete loss of data for one subject. All other subjects were analyzed, with n = 24 HRV Ratio data pairs sampled at random (n = 8 samples each from sleeping, resting, and moving activities) per subject when available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Monitoring | Accuracy of Heart Rate Variability Measured by Low Frequency Content to High Frequency Content Ratio (HRV Ratio) Compared to the Reference Device | 1.1 unitless | Standard Deviation 1.8 |
Primary
Accuracy of Heart Rate Variability Measured by Root Mean Square of Successive Differences (HRV RMSSD) Compared to the Reference Device
Heart Rate Variability RMSSD is measured by the subject device determined by root mean square of successive differences in neighboring RR intervals and will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.
Time frame: 2 days after informed consent
Population: One comparator device malfunctioned, resulting in a complete loss of data for one subject. All other subjects were analyzed, with n = 24 HRV RMSSD data pairs sampled at random (n = 8 samples each from sleeping, resting, and moving activities) per subject when available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Monitoring | Accuracy of Heart Rate Variability Measured by Root Mean Square of Successive Differences (HRV RMSSD) Compared to the Reference Device | 5.1 milliseconds | Standard Deviation 24.9 |
Primary
Accuracy of Posture Classification as Compared to Visual Annotation
The device under test will classify a subjects activity into sleep posture, standing posture, and sitting posture as the subject performs various predefined activities, which are annotated by an observer. The device's Posture Classification will be compared to the observer's annotation. The percentage of correct classifications by the device against indicated visual observation is presented. The percent correct is not a per subject average, but is the percentage of all posture classifications which were correct when compared to ground truth observation.
Time frame: 2 days after informed consent
Population: All subjects were analyzed, with each subject completing n = 5 repetitions of each sleeping / lying (supine, prone, lying left, lying right) and sitting / standing (upright, leaning backward, leaning forward, leaning left, leaning right) postures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Monitoring | Accuracy of Posture Classification as Compared to Visual Annotation | 92.9 percent correct |
Primary
Accuracy of Respiration Rate Measured in Breaths Per Minute Compared to the Reference Device
Respiration rate as measured by the subject device in breaths per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.
Time frame: 2 days after informed consent
Population: All subjects were analyzed, with n = 8 total respiration rate data pairs sampled at random across the two nights of sleep per subject.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Monitoring | Accuracy of Respiration Rate Measured in Breaths Per Minute Compared to the Reference Device | 1.3 breaths per minute | Standard Deviation 2.1 |
Primary
Accuracy of Sleep Onset Time (Hours, Minutes, and Seconds), Sleep Wake Time (Hours, Minutes, and Seconds) as Compared to an Observer's Visual Annotation
Sleep onset and wake times as reported by the device under test will be compared to an observer's visual annotation of the sleep onset and wake times. The Mean Absolute Error (MAE) between times as indicated by the device and observed times is presented.
Time frame: 2 days after informed consent
Population: All subjects were analyzed, with n = 2 sleep onset and n = 2 sleep wake times compared per subject against sleep technician observations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Monitoring | Accuracy of Sleep Onset Time (Hours, Minutes, and Seconds), Sleep Wake Time (Hours, Minutes, and Seconds) as Compared to an Observer's Visual Annotation | Sleep Onset | 6.8 minutes | Standard Deviation 8.43 |
| Device Monitoring | Accuracy of Sleep Onset Time (Hours, Minutes, and Seconds), Sleep Wake Time (Hours, Minutes, and Seconds) as Compared to an Observer's Visual Annotation | Sleep Wake | 11.5 minutes | Standard Deviation 28.5 |
Primary
Accuracy of Step Count Compared to an Observer's Manual Count
The number of steps reported by the device under test during a 6 minute walk test will be compared to an observer's manual count of the number of steps taken.
Time frame: 2 days after informed consent
Population: All subjects performed n=5 six minute walk tests on a treadmill. Instances in which the system classified the subject as walking for at least 95% of the activity were analyzed. The study device step count was compared to the manually observed step count, with the percent error of each test calculated. These errors were averaged and are presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Monitoring | Accuracy of Step Count Compared to an Observer's Manual Count | 2.4 percent error | Standard Deviation 1.9 |
Primary
Number of Sensors That Remained Sufficiently Adhered to Subjects for 24 Hours as Assessed by a 5 Point Scale
The level of sensor adhesion will be assessed by a 5 point scale (0- sensor is greater than or equal to 90% of sensor adhered, 4-sensor completely detached from subject). Sensors receiving scores of 0 and 1 will be determined to have acceptable adhesion, while scores of 2, 3, and 4 will be considered unacceptable adhesion. The percentage of sensors which had acceptable adhesion at sensor removal is presented.
Time frame: 2 days after informed consent
Population: All subjects analyzed, with 6 sensor locations per subject evaluated for adhesion to skin at device removal. Subjects wore n = 4 sensors (two sensors at chest and thigh locations required for algorithmic outputs, and one sensor at shank and one at forearm locations) on Day 1 and n = 2 sensors (chest and thigh algorithm location sensors) on Day 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device Monitoring | Number of Sensors That Remained Sufficiently Adhered to Subjects for 24 Hours as Assessed by a 5 Point Scale | All Sensors | 83 percent passing |
| Device Monitoring | Number of Sensors That Remained Sufficiently Adhered to Subjects for 24 Hours as Assessed by a 5 Point Scale | Sensors for Algorithm Outputs (Chest and Thigh) | 92 percent passing |