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

Not Applicable

Completed

• Conditions: Healthy Normals
• Interventions: Device: Physiological signal monitor; Device: Heart rate and heart rate variability comparison device; Device: Respiration rate comparison device; Other: Activity classification

• Registration Number: NCT03257189
• Lead Sponsor: MC10 Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-31
• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-22
• Primary Completion: 2017-08-25
• Study Completion: 2017-08-30
• Results First Submitted: 2018-12-04
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-22
• Last Update Submitted: 2019-01-22
• Results First Posted: 2019-01-25
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Heart rate and heart rate variability comparison device	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.
Single Arm	Physiological signal monitor	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.
Single Arm	Respiration rate comparison device	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.
Single Arm	Activity classification	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.

Primary Outcome Measures

Name	Time	Method
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 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 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 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 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 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 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.

Trial Locations

Locations (1)

CTI Clinical Research Center; 🇺🇸 Cincinnati, Ohio, United States