Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data

• Sponsor: MC10 Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03257189
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Days): 30
• Patients Per Site Per Month: 30.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Normals	Device: Physiological signal monitor; Device: Heart rate and heart rate variability comparison device; Device: Respiration rate comparison device; Other: Activity classification	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Study to Evaluate the Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data in Healthcare and Remote Settings
• Actual Study Start Date: Jul 31, 2017
• Actual Primary Completion Date: Aug 25, 2017
• Actual Study Completion Date: Aug 30, 2017

Arms and Interventions

Arm

Intervention/Treatment

Other: Single Arm 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.

Device: 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.; Device: Heart rate and heart rate variability comparison device; FDA cleared reference device that monitors heart rate and heart rate variability in subjects; Device: Respiration rate comparison device; FDA cleared reference device that monitors respiration rate in subjects; Other: Activity classification; Visual annotation of subject posture and other activities used for reference

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CTI Clinical Research Center	Cincinnati	Ohio	United States	45212

Sponsors and Collaborators

• MC10 Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jun 21, 2017
• Statistical Analysis Plan - Sep 14, 2017

More Information

Publications

None provided.

• Responsible Party: MC10 Inc.
• ClinicalTrials.gov Identifier: NCT03257189
• Other Study ID Numbers: MC10-PTL-103
• First Posted: Aug 22, 2017
• Last Update Posted: Jan 25, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

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.

Arm/Group Title	Device Monitoring
Arm/Group Description	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
Period Title: Overall Study
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Device Monitoring
Arm/Group Description	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
Overall Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.9 (10.1)
Sex: Female, Male (Count of Participants)
Female	7 23.3%
Male	23 76.7%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	30 100%
Height (cm) (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	172.17 (8.61)
Weight (kg) (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	83.33 (11.63)
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.12 (3.57)

Outcome Measures

1. Primary Outcome

Title	Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Device Monitoring
Arm/Group Description	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
Measure Participants	29
Mean (Standard Deviation) [beats per minute]	2.0 (5.1)

2. Primary Outcome

Title	Accuracy of Heart Rate Variability Measured by Root Mean Square of Successive Differences (HRV RMSSD) Compared to the Reference Device
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Device Monitoring
Arm/Group Description	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
Measure Participants	29
Mean (Standard Deviation) [milliseconds]	5.1 (24.9)

3. Primary Outcome

Title	Accuracy of Heart Rate Variability Measured by Low Frequency Content to High Frequency Content Ratio (HRV Ratio) Compared to the Reference Device
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Device Monitoring
Arm/Group Description	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
Measure Participants	29
Mean (Standard Deviation) [unitless]	1.1 (1.8)

4. Primary Outcome

Title	Accuracy of Respiration Rate Measured in Breaths Per Minute Compared to the Reference Device
Description	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

Outcome Measure Data

Analysis Population Description

All subjects were analyzed, with n = 8 total respiration rate data pairs sampled at random across the two nights of sleep per subject.

Arm/Group Title	Device Monitoring
Arm/Group Description	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
Measure Participants	30
Mean (Standard Deviation) [breaths per minute]	1.3 (2.1)

5. Primary Outcome

Title	Accuracy of Activity Classification as Compared to Visual Annotation
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Device Monitoring
Arm/Group Description	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
Measure Participants	30
Number [percent correct]	98.7

6. Primary Outcome

Title	Accuracy of Step Count Compared to an Observer's Manual Count
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Device Monitoring
Arm/Group Description	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
Measure Participants	30
Mean (Standard Deviation) [percent error]	2.4 (1.9)

7. Primary Outcome

Title	Accuracy of Sleep Onset Time (Hours, Minutes, and Seconds), Sleep Wake Time (Hours, Minutes, and Seconds) as Compared to an Observer's Visual Annotation
Description	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

Outcome Measure Data

Analysis Population Description

All subjects were analyzed, with n = 2 sleep onset and n = 2 sleep wake times compared per subject against sleep technician observations

Arm/Group Title	Device Monitoring
Arm/Group Description	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
Measure Participants	30
Sleep Onset	6.8 (8.43)
Sleep Wake	11.5 (28.5)

8. Primary Outcome

Title	Accuracy of Posture Classification as Compared to Visual Annotation
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Device Monitoring
Arm/Group Description	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
Measure Participants	30
Number [percent correct]	92.9

9. Primary Outcome

Title	Number of Sensors That Remained Sufficiently Adhered to Subjects for 24 Hours as Assessed by a 5 Point Scale
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Device Monitoring
Arm/Group Description	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
Measure Participants	30
Measure Total Sensors Evaluated for Adhesion	180
All Sensors	83
Sensors for Algorithm Outputs (Chest and Thigh)	92

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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.
Arm/Group Title	Device Monitoring
Arm/Group Description	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
All Cause Mortality
	Device Monitoring
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Serious Adverse Events
	Device Monitoring
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Device Monitoring
	Affected / at Risk (%)	# Events
Total	1/30 (3.3%)
Respiratory, thoracic and mediastinal disorders
Nasal Congestion	1/30 (3.3%)	1

Limitations/Caveats

This study design was based off of the predicate device's pivotal study design. It was limited to healthy subjects only.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.