RecruitingNot Applicable

Controlled Desaturation Study for Perin Health Patch Validation

United States25 participantsStarted 2024-10-21

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Immediately after the intervention

Trial details

NCT IDNCT06680700

SponsorPerin Health Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-31

Contact for this trial

Ian McLane, Ph.D.

310-997-8176 clinicalstudies@phasemargin.com

View on ClinicalTrials.gov More Oxygen Saturation Measurement trials