Controlled Desaturation Study for Perin Health Patch Validation

Conditions

• Oxygen Saturation Measurement

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• Perin Health Patch — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Oct 21, 2024

Status verified

Nov 2024

Primary completion

Dec 31, 2024

Completion

Mar 31, 2025

Study Design

Enrollment

25 participants (estimated)

Arms

• Arm: Healthy volunteers
  Healthy adult volunteers aged 18-50, who meet strict inclusion criteria to ensure safety and consistency in the results. Participants must be in good general health, with no history of respiratory, cardiovascular, or other systemic diseases that could pose additional risks during controlled desaturation. All participants are fully vaccinated for COVID-19, fluent in English, and capable of understanding and complying with the study procedures.

Primary Outcome Measure

Accuracy of SpO2 Measurements by Perin Health Patch Compared to Reference Pulse Oximeter [ Time Frame: Immediately after the intervention ]

Central Contacts

• Ian McLane, Ph.D.
  310-997-8176
  [email protected]

Locations (1)

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