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RECRUITING
NCT06680700

Controlled Desaturation Study for Perin Health Patch Validation

Sponsor: Perin Health Devices

View on ClinicalTrials.gov

Summary

This study aims to test the accuracy of the Perin Health Patch (PHP), a non-invasive, chest-worn device that measures blood oxygen levels, by comparing its readings to a standard pulse oximeter device. The PHP device uses light sensors to measure blood oxygen saturation (SpO2), similar to how standard pulse oximeters work, and could allow for continuous remote monitoring at home. Participants in this study will breathe low-oxygen air through a mask to simulate different oxygen levels in a controlled environment. The goal is to see if the PHP device can accurately measure blood oxygen levels under different conditions and meet safety standards set by the FDA and international guidelines.

Official title: Controlled Desaturation Study for Perin Health Patch Pulse Oximetry Validation

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

25

Start Date

2024-10-21

Completion Date

2025-03-31

Last Updated

2024-11-08

Healthy Volunteers

Yes

Interventions

DEVICE

Perin Health Patch

The Perin Health Patch (PHP) is a non-invasive, chest-worn device designed to monitor blood oxygen saturation (SpO2) and additional vital signs, including heart rate, respiratory rate, ECG, and bioimpedance (BioZ). Unlike traditional fingertip pulse oximeters, the PHP integrates multi-wavelength photoplethysmography (PPG) sensors with ECG and BioZ technology, allowing for continuous SpO2 tracking even during movement and daily activities.

Locations (1)

Perin Health Devices

Woodland Hills, California, United States