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Controlled Desaturation Study for Perin Health Patch Validation
Sponsor: Perin Health Devices
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
Conditions
Interventions
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