Smart Mask V1: measuring blood oxygen and pulse from a PAP-style face mask
Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate
This test will see if the Smart Mask V1 can accurately measure blood oxygen (SpO2) and pulse rate in healthy adults aged 18–65.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Pathway Medtech, LLC. Industry-sponsored |
| Locations | 1 site (Genk) |
| Trial ID | NCT07086742 on ClinicalTrials.gov |
What this trial studies
Healthy adult volunteers (ASA I–II, 18–65 years) will wear the Smart Mask V1 in a sealed, climate-controlled normobaric hypoxia room while SpO2 and pulse rate are recorded and compared to an FDA-cleared fingertip pulse oximeter. The protocol has two sequential phases: a non-invasive phase comparing optical measurements to the fingertip oximeter and an invasive phase that adds blood sampling for laboratory CO-oximetry across SpO2 levels of roughly 70–100%. Hypoxia will be induced gradually with continuous medical monitoring and predefined safety exit criteria (e.g., SpO2 < 73%) and emergency equipment on site. Analyses will quantify agreement between the Smart Mask and reference devices and test whether skin pigmentation affects SpO2 and pulse measurement accuracy.
Who should consider this trial
Good fit: Ideal participants are healthy adults aged 18–65 with ASA I–II status who consent to controlled hypoxia exposure and, in the invasive phase, blood sampling.
Not a fit: People with moderate-to-severe heart, lung, kidney or liver disease, significant anemia or hemoglobinopathy, obesity (BMI ≥ 35), current hypoxia, or other serious systemic illness are excluded and would not benefit from this validation.
Why it matters
Potential benefit: If successful, the Smart Mask could provide reliable, mask-integrated continuous SpO2 and pulse monitoring during positive airway pressure use without a fingertip sensor.
How similar studies have performed: Prior validation work comparing pulse oximeters to CO-oximetry and PPG at alternate sites has shown mixed results and documented skin pigmentation effects, so this device builds on established methods but tests a novel mask-based sensor configuration.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Genk
- Complementair Medisch Centrum (CMC) Europe — Genk, Belgium (Recruiting)
Study contacts
- Principal investigator: Raf De Jongh, M.D. — Complementair Medisch Centrum (CMC) Europe
- Study coordinator: Raf De Jongh, M.D.
- Email: raf.dejongh@skynet.be
- Phone: +32 477 514 77
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.