Controlled Desaturation Study for Perin Health Patch Validation
ConditionOxygen Saturation Measurement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorPerin Health Devices
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Children (under the age of 18)
Adults above 50 years old
History of heart, lung, kidney, or liver disease.
Obesity (BMI > 30),
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Perin Health Patch
DeviceThe 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Healthy volunteers1 intervention
Trial outcomes
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.
Time frame
Immediately after the interventionSecondary outcomes
1
SpO2 Accuracy During Motion
This outcome measures the accuracy of SpO2 readings from the PHP compared to a reference pulse oximeter while participants are in motion (e.g., walking on a treadmill). It specifically assesses if movement impacts the PHP's ability to maintain SpO2 accuracy within ISO 80601-2-61 standards, with a target ARMS of ≤ 4.0% SpO2.
Time frame
Immediately after the interventionSponsors and contacts
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Source ClinicalTrials.gov