Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate

Recruiting N/A Interventional Study
Sleep-disordered Breathing (SDB) Sleep Apnea Sleep Quality
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 65
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
36 (estimated)
Sponsor
Pathway Medtech, LLC. · Industry
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About This Trial
The goal of this clinical study is to investigate a new medical device, the Smart Mask V1 System (herein 'Smart Mask'), and particularly its measurements of blood oxygen levels (SpO2) and pulse rate (PR) in healthy adults aged 18 to 65. More specifically, the study is directed at answering the following questions: * Can the Smart Mask accurately measure SpO2 levels compared to established refere…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Healthy subjects with ASA health score of I or II * Subjects aged between ≥ 18 and ≤ 65 years. * Subjects who have provided informed consent and are willing to comply with the study procedures. Exclusion Criteria: * Heavy smokers or individuals exposed to high levels of carb…
Contacts

Raf De Jongh, M.D.

+32 477 514 77

raf.dejongh@skynet.be

CONTACT