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

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Evaluate the Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data in Healthcare and Remote Settings

Conditions
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Healthy Normals

Intervention / Treatment
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* Device: Physiological signal monitor
* Device: Heart rate and heart rate variability comparison device
* Device: Respiration rate comparison device
* Other: Activity classification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female volunteers, at least 18 years of age at the time of screening visit; Fluent in English; The subject is willing to comply with the protocol specified evaluations; Subject is willing and cognitively able to sign informed consent Exclusion Criteria: Pregnancy; Positive urine drug screen History of active (clinically significant) skin disorders; History of allergic response to silicones or adhesives; Subjects with electronic implants of any kind (e.g. pacemaker) History of sleep disorders or self-reported insomnia or other sleep conditions; Broken, damaged or irritated skin or rashes near the sensor application sites; Subjects that are MC10 employees or shareholders, or a spouse or child of an MC10 employee or shareholder; Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>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<br>* Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.<br>Device: Heart rate and heart rate variability comparison device<br>* FDA cleared reference device that monitors heart rate and heart rate variability in subjects<br>Device: Respiration rate comparison device<br>* FDA cleared reference device that monitors respiration rate in subjects<br>Other: Activity classification<br>* Visual annotation of subject posture and other activities used for reference<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 days after informed consent | 
| 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. | 2 days after informed consent | 
| 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. | 2 days after informed consent | 
| 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. | 2 days after informed consent | 
| 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. | 2 days after informed consent | 
| 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. | 2 days after informed consent | 
| 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. | 2 days after informed consent | 
| 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. | 2 days after informed consent | 
| 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. | 2 days after informed consent |