Controlled Desaturation Study for Perin Health Patch Pulse Oximetry Validation
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.
Description
The Perin Health Patch (PHP) is a non-invasive, chest-worn medical device that continuously measures blood oxygen saturation (SpO2), alongside other vital signs. The PHP's performance will be assessed under controlled hypoxemia (low oxygen levels), where its readings will be compared to a standard pulse oximeter validated against co-oximeter reference values. In this single-site, prospective study, up to 25 healthy adult volunteers will undergo controlled desaturation sessions. During each session, a mask delivering a low-oxygen gas mixture will be used to safely lower participants' SpO2 leve…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Adults aged 18 years to 50 years * The subject is in good general health with no evidence of any medical problems, * Fully vaccinated for COVID-19 * Fluent in both written and spoken English * Willing and able to provide informed consent, * Able to comply with study procedure. Exclusion Criteria: * Children (under the age of 18) * Adults above 50 years old * History of heart, lung, kidney, or liver disease. * Obesity (BMI \> 30), * Diagnosis of asthma, sleep apnea, or use of CPAP. * Diagnosis of Raynaud's disease * Unacceptable collateral circulation based on an exam b…
Interventions
- DevicePerin 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.
Location
- Perin Health DevicesWoodland Hills, California