Trial Outcomes & Findings for Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data (NCT NCT03257189)
NCT ID: NCT03257189
Last Updated: 2019-01-25
Results Overview
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.
COMPLETED
NA
30 participants
2 days after informed consent
2019-01-25
Participant Flow
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.
Participant milestones
| Measure |
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
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|---|---|
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Overall Study
STARTED
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30
|
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Overall Study
COMPLETED
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30
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Device Monitoring
n=30 Participants
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
|
|---|---|
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Age, Continuous
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35.9 years
STANDARD_DEVIATION 10.1 • n=30 Participants
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Sex: Female, Male
Female
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7 Participants
n=30 Participants
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Sex: Female, Male
Male
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23 Participants
n=30 Participants
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Region of Enrollment
United States
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30 participants
n=30 Participants
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Height (cm)
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172.17 centimeters
STANDARD_DEVIATION 8.61 • n=30 Participants
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Weight (kg)
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83.33 kilograms
STANDARD_DEVIATION 11.63 • n=30 Participants
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BMI
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28.12 kg/m^2
STANDARD_DEVIATION 3.57 • n=30 Participants
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PRIMARY outcome
Timeframe: 2 days after informed consentPopulation: 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.
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.
Outcome measures
| Measure |
Device Monitoring
n=29 Participants
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
|
|---|---|
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Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device
|
2.0 beats per minute
Standard Deviation 5.1
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PRIMARY outcome
Timeframe: 2 days after informed consentPopulation: 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.
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.
Outcome measures
| Measure |
Device Monitoring
n=29 Participants
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
|
|---|---|
|
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
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PRIMARY outcome
Timeframe: 2 days after informed consentPopulation: 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.
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.
Outcome measures
| Measure |
Device Monitoring
n=29 Participants
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
|
|---|---|
|
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
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PRIMARY outcome
Timeframe: 2 days after informed consentPopulation: All subjects were analyzed, with n = 8 total respiration rate data pairs sampled at random across the two nights of sleep per subject.
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.
Outcome measures
| Measure |
Device Monitoring
n=30 Participants
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
|
|---|---|
|
Accuracy of Respiration Rate Measured in Breaths Per Minute Compared to the Reference Device
|
1.3 breaths per minute
Standard Deviation 2.1
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PRIMARY outcome
Timeframe: 2 days after informed consentPopulation: 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.
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.
Outcome measures
| Measure |
Device Monitoring
n=30 Participants
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
|
|---|---|
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Accuracy of Activity Classification as Compared to Visual Annotation
|
98.7 percent correct
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PRIMARY outcome
Timeframe: 2 days after informed consentPopulation: 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.
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.
Outcome measures
| Measure |
Device Monitoring
n=30 Participants
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
|
|---|---|
|
Accuracy of Step Count Compared to an Observer's Manual Count
|
2.4 percent error
Standard Deviation 1.9
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PRIMARY outcome
Timeframe: 2 days after informed consentPopulation: All subjects were analyzed, with n = 2 sleep onset and n = 2 sleep wake times compared per subject against sleep technician observations
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.
Outcome measures
| Measure |
Device Monitoring
n=30 Participants
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
|
|---|---|
|
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
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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
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PRIMARY outcome
Timeframe: 2 days after informed consentPopulation: 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.
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.
Outcome measures
| Measure |
Device Monitoring
n=30 Participants
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
|
|---|---|
|
Accuracy of Posture Classification as Compared to Visual Annotation
|
92.9 percent correct
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PRIMARY outcome
Timeframe: 2 days after informed consentPopulation: 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.
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.
Outcome measures
| Measure |
Device Monitoring
n=180 Total Sensors Evaluated for Adhesion
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
|
|---|---|
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Number of Sensors That Remained Sufficiently Adhered to Subjects for 24 Hours as Assessed by a 5 Point Scale
All Sensors
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83 percent passing
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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)
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92 percent passing
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Adverse Events
Device Monitoring
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Device Monitoring
n=30 participants at risk
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
|
|---|---|
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Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.3%
1/30 • Number of events 1 • Adverse event data was available for collection for 3 days after the subject left the clinic. Subjects were evaluated throughout their 3 days at the clinic and a safety follow up phone call was conducted 3 days after their last clinic visit.
All adverse events (all-cause mortality, serious, and non-serious) were collected. The study was inherently low risk, as the test device is a non-significant risk device and study population was limited to healthy volunteers.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place