At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Evaluate the Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data in Healthcare and Remote Settings
In Brief
A clinical study evaluating Physiological signal monitor, Heart rate and heart rate variability comparison device, and 2 other interventions for Healthy Normals. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.
FDA cleared reference device that monitors heart rate and heart rate variability in subjects
FDA cleared reference device that monitors respiration rate in subjects
Visual annotation of subject posture and other activities used for reference