Actively Recruiting
Controlled Desaturation Study for Perin Health Patch Validation
Led by Perin Health Devices · Updated on 2024-11-08
25
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Controlled Desaturation Study for Perin Health Patch Validation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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 would interfere with the sensors working correctly
- Any evidence of medical problems or poor general health
- Any symptoms related to COVID-19
- Not 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Perin Health Devices
Woodland Hills, California, United States, 91364
Actively Recruiting
Research Team
I
Ian McLane, Ph.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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