Clinical trial NCT03257189: Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Normals
Lead sponsor: MC10 Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device
timeFrame: 2 days after informed consent
measure: Accuracy of Heart Rate Variability Measured by Root Mean Square of Successive Differences (HRV RMSSD) Compared to the Reference Device
timeFrame: 2 days after informed consent
measure: Accuracy of Heart Rate Variability Measured by Low Frequency Content to High Frequency Content Ratio (HRV Ratio) Compared to the Reference Device
timeFrame: 2 days after informed consent
measure: Accuracy of Respiration Rate Measured in Breaths Per Minute Compared to the Reference Device
timeFrame: 2 days after informed consent
measure: Accuracy of Activity Classification as Compared to Visual Annotation
timeFrame: 2 days after informed consent
measure: Accuracy of Step Count Compared to an Observer's Manual Count
timeFrame: 2 days after informed consent
measure: Accuracy of Sleep Onset Time (Hours, Minutes, and Seconds), Sleep Wake Time (Hours, Minutes, and Seconds) as Compared to an Observer's Visual Annotation
timeFrame: 2 days after informed consent
measure: Accuracy of Posture Classification as Compared to Visual Annotation
timeFrame: 2 days after informed consent
measure: Number of Sensors That Remained Sufficiently Adhered to Subjects for 24 Hours as Assessed by a 5 Point Scale
timeFrame: 2 days after informed consent
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
Study officials:
References: