Controlled Desaturation Study for Perin Health Patch Validation

NCT06680700 | Recruiting FDA Device

• 1 other identifier: PHD-004-24
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pulse Oximeter; Oxygen Saturation; Wearable

Outcome Measures

Primary Outcomes (1)

• Accuracy of SpO2 Measurements by Perin Health Patch Compared to Reference Pulse Oximeter

  The primary outcome measure is the accuracy of blood oxygen saturation (SpO2) readings from the Perin Health Patch (PHP) in comparison to those from a reference pulse oximeter. Accuracy will be determined by calculating the mean difference (bias) and standard deviation of differences (precision) between the SpO2 measurements obtained from the PHP and those from the reference devices across a range of hypoxemic conditions (70-100% SpO2). The PHP's SpO2 accuracy will be assessed using a root-mean-square difference (ARMS) in accordance with ISO 80601-2-61 standards, with a target ARMS of ≤ 4.0% SpO2 across the specified range.

  Immediately after the intervention

Secondary Outcomes (1)

• SpO2 Accuracy During Motion

  Immediately after the intervention

Study Arms (1)

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.

Device: Perin Health Patch

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.

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of healthy adult volunteers recruited from the general community surrounding Woodland Hills, CA. The population is selected to ensure a controlled environment with minimal health variability, allowing for a precise assessment of the Perin Health Patch's performance in measuring blood oxygen saturation (SpO2) and other physiological metrics under controlled conditions of hypoxemia. All participants will be screened for general health and suitability to participate in a desaturation study, ensuring a homogenous, low-risk sample for accurate device validation.

You may qualify if:

• 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.

You may not qualify if:

• 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 by the investigator (Allen's test).
• Pregnant, lactating or trying to get pregnant
• Current smoker
• History of diabetes
• Clotting disorder
• Hemoglobinopathy or history of anemia
• History of fainting or vasovagal response
• Any other serious systemic illness
• Any other condition which, in the opinion of the investigators, would make them unsuitable for the study,

Sponsors & Collaborators

• Perin Health Devices: lead

Study Sites (1)

Perin Health Devices

Woodland Hills, California, 91364, United States

RECRUITING

Study Officials

• Ian M McLane, Ph.D.

  Perin Health Devices

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian McLane, Ph.D.

CONTACT

310-997-8176; clinicalstudies@phasemargin.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 8, 2024
• Study Start: October 21, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)