Controlled Desaturation Study for Perin Health Patch Validation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-21

Study Completion Date

2025-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pulse Oximeter Validation Study for the Perin Health Patch

NCT07027150

Hypoxia

COMPLETED

Respiratory Rate Validation Study

NCT07147907

Respiration Rate Monitoring, Physiologic

COMPLETED

N600X Low Saturation Accuracy Validation

NCT05532670

Hypoxia

COMPLETED

Clinical Study of Peripheral Capillary Oxygen Saturation (SpO2): Vital Signs Patch (VSP)

NCT01899911

Desaturation of Blood

COMPLETED NA

Pulse Oximeter Accuracy in Healthy Humans During Hypoxia

NCT06142019

Hypoxia Skin Pigmentation

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Perin Health Patch (PHP) is a non-invasive, chest-worn medical device that continuously measures blood oxygen saturation (SpO2), alongside other vital signs. The PHP's performance will be assessed under controlled hypoxemia (low oxygen levels), where its readings will be compared to a standard pulse oximeter validated against co-oximeter reference values.

In this single-site, prospective study, up to 25 healthy adult volunteers will undergo controlled desaturation sessions. During each session, a mask delivering a low-oxygen gas mixture will be used to safely lower participants' SpO2 levels. This method simulates a range of oxygenation states, from 70% to 100% SpO2, which is critical for testing the device's accuracy across a clinically relevant range. The PHP's readings will be captured alongside those from two standard pulse oximeters placed on both hands. Participants will be carefully monitored by clinical staff throughout the study, with emergency oxygen and other medical equipment readily available to ensure participant safety.

Participants will complete two desaturation "runs," each lasting approximately 10-15 minutes, with brief breaks between sessions. During some sessions, participants may be asked to walk slowly on a treadmill to simulate movement conditions. This study design aligns with the ISO 80601-2-61 standard, supporting robust accuracy assessments under both stationary and motion conditions.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oxygen Saturation Measurement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Perin Health Patch

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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,
* Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly,
* Any evidence, in the opinion of the investigators, of medical problems or poor general health
* Any symptoms related to COVID-19
* No vaccinated for COVID-19
* Recent injection with methylene blue
* History of reactions to medical adhesives,
* Unable or unwilling to provide informed consent,
* Inability to comply with the study procedure,
* Non-English Speaker.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes