Smart mask aims to measure blood oxygen through your face
NCT ID NCT07086742
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing a new face mask, the Smart Mask V1 System, that uses built-in light sensors to measure blood oxygen (SpO2) and pulse rate. The study enrolls healthy adults aged 18 to 65 who wear the mask while breathing air with gradually lower oxygen levels in a special room. The goal is to see if the mask's readings match those from standard fingertip oximeters and blood tests, and whether skin pigmentation affects accuracy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Smart Mask V1 System, a face mask with built-in light sensors that measure blood oxygen and pulse rate
- What this could lead to
- If it works, the Smart Mask could offer a comfortable way to monitor breathing and oxygen levels during sleep, possibly helping detect sleep apnea or other breathing problems.
- What could go wrong
- This is an early validation study in healthy adults, so the mask may not measure as accurately as standard devices, especially across different skin tones. The study does not test whether the mask improves health outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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53 people
The number who actually took part.
- Started
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Jul 2025
- Finished
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Nov 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 carbon monoxide resulting in elevated carboxyhemoglobin levels. * Individuals with conditions that result in elevated methemoglobin levels. * Individuals with hypoxia (SpO2 \< 95% at 21% O2). * Severe claustrophobia. * Subjects known with altitude sickness. * Subjects who are obese (BMI ≥ 35 kg/m2). * Subjects with a known history of moderate to severe heart, lung, kidney or liver disease. * Subjects diagnosed with moderate to severe asthma. * Subjects with a hemoglobinopathy or history of anemia, e.g. sickle cell anemia, thalassemia, that in the investigator's opinion, would make them unsuitable for study participation. * Subjects with any other serious systemic illness. * Any injury, deformity, or abnormality at the sensor sites that, in the investigator's opinion, would interfere with the correct functioning of the test or reference devices. * Subjects with a history of fainting or vasovagal response. * Subjects with a history of sensitivity or allergy to local anesthetics or disinfectants if included in the IN study. * Subjects diagnosed with Raynaud's disease. * Subjects with unacceptable collateral circulation based on examination by the investigator. * Subjects who are pregnant, lactating or trying to become pregnant. * Subjects unable or unwilling to provide informed consent or comply with study procedures. * Subjects with any other condition that, in the investigator's opinion, would make them unsuitable for the study. * Subjects who refuse to remove nail polish from their index finger. * Volunteers not willing to remove facial make-up.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Complementair Medisch Centrum (CMC) Europe
Genk, 3600, Belgium
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