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

Recruiting now · Not applicable

Conditions studied: Sleep-disordered Breathing (SDB), Sleep Apnea, Sleep Quality

In brief

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 reference devices (reference oximeters, blood gas) throughout the range of SpO2 \~ 70 - 100%? * Can the Smart Mask accurately measure PR during the same conditions? * Does skin pigmentation impact the accuracy of Smart Mask's measurements of SpO2 and PR. The following reference devices will be used in the study: * An FDA-cleared fingertip pulse oximeter (Nellcor Portable SpO2 Patient Monitoring System, PM10N) * A laboratory-grade CO-oximeter (Radiometer ABL90 FLEX) that analyzes oxygen saturation from blood samples. Study participants will: * Wear the Smart Mask on their face and a fingertip pulse oximeter while lying down * Breathe air with gradually reduced oxygen levels inside a specialized hypoxia room while being closely. * In a second phase of the study, have a catheter inserted into a wrist artery for blood sampling to directly measure oxygen levels with the CO-oximeter.

Key facts

Study ID

NCT07086742

Run by

Pathway Medtech, LLC.

People needed

36

Starts

2025-09-01

Expected to finish

2025-12-31

Last updated by the study team

2025-08-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Complementair Medisch Centrum (CMC) Europe — Genk, Belgium (enrolling)

Full record on ClinicalTrials.gov

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