Controlled Desaturation Study for Perin Health Patch Pulse Oximetry Validation

What this Trial Is About

Researchers are evaluating the accuracy of the Perin Health Patch (PHP), a non-invasive chest-worn device that continuously measures blood oxygen saturation (SpO2) and other vital signs. This study aims to compare the PHP's readings to those from standard pulse oximeters in healthy adults aged 18 to 50. Participants will breathe low-oxygen air in a controlled setting to simulate various oxygen levels and test the device's performance. The goal is to assess whether the PHP meets FDA and international safety standards for oxygen monitoring. The study involves up to 25 healthy adult volunteers undergoing controlled desaturation sessions where oxygen levels are lowered safely using a mask with low-oxygen gas. Participants will complete two sessions lasting 10-15 minutes each, with breaks in between. Some sessions may include slow walking on a treadmill to assess the device's accuracy during movement. The PHP's measurements will be compared with two standard pulse oximeters placed on both hands to validate performance under both stationary and motion conditions. During the study, participants will be closely monitored by clinical staff, with emergency oxygen and medical equipment available for safety. Assessments include continuous SpO2 measurement with the PHP and reference pulse oximeters. The primary outcome is the accuracy of SpO2 readings immediately after intervention, including during motion. The total participation involves the desaturation sessions and observation under controlled conditions. Participants must comply with study procedures and provide informed consent.

Controlled Desaturation Study for Perin Health Patch Validation