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

MC10

Status: Completed

Conditions: Healthy Normals

Treatments: Other: Activity classification; Device: Respiration rate comparison device; Device: Physiological signal monitor; Device: Heart rate and heart rate variability comparison device

Study type: Interventional

Funder types: Industry

Identifiers

NCT03257189

MC10-PTL-103

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Single Arm

Other 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.

Treatment:

Device: Heart rate and heart rate variability comparison device

Device: Physiological signal monitor

Device: Respiration rate comparison device

Other: Activity classification