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Controlled Desaturation Study for Perin Health Patch Validation

NCT06680700 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2024-11-08

No results posted yet for this study

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.

Conditions

  • Oxygen Saturation Measurement

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.

Sponsors & Collaborators

  • Perin Health Devices

    lead INDUSTRY

Principal Investigators

  • Ian M McLane, Ph.D. · Perin Health Devices

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2024-12-31
Completion
2025-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06680700 on ClinicalTrials.gov