NCT06680700

Controlled Desaturation Study for Perin Health Patch Validation

Controlled Desaturation Study for Perin Health Patch Pulse Oximetry Validation

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Perin Health Devices · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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 levels. This method simulates a range of oxygenation states, from 70% to 100% SpO2, which is critical for testing the device's accuracy across a clinically relevant range. The PHP's readings will be captured alongside those from two standard pulse oximeters placed on both hands. Participants will be carefully monitored by clinical staff throughout the study, with emergency oxygen and other medical equipment readily available to ensure participant safety. Participants will complete two desaturation "runs," each lasting approximately 10-15 minutes, with brief breaks between sessions. During some sessions, participants may be asked to walk slowly on a treadmill to simulate movement conditions. This study design aligns with the ISO 80601-2-61 standard, supporting robust accuracy assessments under both stationary and motion conditions.

Conditions

• Oxygen Saturation Measurement

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-21
• Primary completion: 2024-12-31
• Completion: 2025-03-31
• First posted: 2024-11-08
• Last updated: 2024-11-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study