Testing a new wearable device for measuring blood oxygen levels
Official title: Controlled Desaturation Study for Perin Health Patch Pulse Oximetry Validation
Run by Perin Health Devices · NCT06680700 · Data updated 2026-11-12
This study is testing a new wearable device that measures blood oxygen levels in healthy adults to see how well it works compared to standard devices.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Perin Health Devices Industry-sponsored |
| Locations | 1 site (Woodland Hills, California) |
| Status | Recruiting |
| Started | October 21, 2024 |
| Main results expected | December 31, 2024 |
| Study ends | March 31, 2025 |
| Registry record updated | November 8, 2024 |
| Trial ID | NCT06680700 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy adults aged 18 to 50 who are fully vaccinated for COVID-19 and can comply with study procedures.
✕Probably not a fit
Patients with pre-existing conditions such as heart or lung diseases, or those over 50 years old, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the accuracy of the Perin Health Patch (PHP), a non-invasive device worn on the chest that continuously measures blood oxygen saturation. Participants will breathe low-oxygen air to simulate various oxygen levels while their readings are compared to standard pulse oximeters. The study aims to assess the PHP's performance under controlled conditions, ensuring it meets safety standards and can provide reliable data for remote monitoring. Up to 25 healthy adults will participate in this single-site study, which includes controlled desaturation sessions and monitoring by clinical staff.
Why it matters
Potential benefit: If successful, this device could enable continuous and accurate monitoring of blood oxygen levels in patients at home.
How similar studies have gone: While similar studies have explored wearable devices for monitoring vital signs, the specific approach of the PHP in this controlled setting is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Perin Health Devices
Woodland Hills, California, United States Recruiting
Study contacts
- Principal investigator: Ian M McLane, Ph.D. — Perin Health Devices
- Study coordinator: Ian McLane, Ph.D.
- Email: clinicalstudies@phasemargin.com
- Phone: 310-997-8176
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.