Controlled Desaturation Study for Perin Health Patch Validation
Controlled Desaturation Study for Perin Health Patch Pulse Oximetry Validation
Perin Health Devices
25 participants
Oct 21, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria24
- 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.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06680700