Controlled Desaturation Study for Perin Health Patch Validation

Recruiting now

Conditions studied: Oxygen Saturation Measurement

In brief

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.

Key facts

Study ID

NCT06680700

Run by

Perin Health Devices

People needed

25

Starts

2024-10-21

Expected to finish

2025-03-31

Last updated by the study team

2024-11-08

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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,
• 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 is running

• Perin Health Devices — Woodland Hills, California, United States (enrolling)

Full record on ClinicalTrials.gov

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