An interventional study of Smart Mask V1 System in Sleep-disordered Breathing (SDB), Sleep Apnea and Sleep Quality, sponsored by Pathway Medtech, LLC.. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Pathway Medtech, LLC. · Not applicable, Interventional, and Other
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:
The following reference devices will be used in the study:
Study participants will:
This clinical study evaluates the Smart Mask V1 System, a medical device designed to measure blood oxygen saturation (SpO2) and pulse rate (PR) using reflective photoplethysmography (PPG) sensors integrated into a face mask intended for use with positive airway pressure (PAP) therapy. The study aims to validate the accuracy of the Smart Mask's optical measurements under controlled, progressive hypoxia conditions in healthy adult volunteers.
The investigation is divided into two sequential phases; Non-Invasive (NI) and Invasive (IN) Study. All study sessions are conducted at the Complementary Medical Centre (CMC) in Genk, Belgium, within a certified normobaric hypoxia room. This room is sealed and climate-controlled, equipped with oxygen and carbon dioxide sensors to maintain a stable and safe hypoxic environment.
Hypoxia is induced gradually to reduce any discomfort or potential risk to participants. Comprehensive safety protocols are in place to protect volunteers. These include medical screening and obtaining informed consent prior to enrollment, as well as real-time monitoring by trained medical staff throughout the exposure. Immediate exit protocols are activated if a participant's SpO2 falls below 73% or if symptoms of acute mountain sickness are observed. Emergency oxygen and resuscitation equipment are readily available on-site. Additionally, participants are reminded that they may withdraw from the study at any time without penalty.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's enrollment of 53 is close to the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Pathway Medtech, LLC. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The Non-Invasive (NI) study is designed to calibrate the Smart Mask's algorithms using data collected from healthy volunteers exposed to controlled, progressive hypoxia. During the study, participants lie in a supine position in a normobaric hypoxia room while breathing room air with gradually reduced oxygen levels, with the fraction of inspired oxygen (FiO2) decreasing from approximately 21% to as low as 9.5%. The Smart Mask derives SpO2 values from reflected light signals detected by its integrated sensors. Simultaneously, a benchmark pulse oximeter (Nellcor PM10N), worn on the finger, provides reference SpO2 and pulse rate (PR) values for algorithm calibration. Data from reference device are used to refine the conversion of raw photoplethysmography (PPG) signals into SpO2 and PR readings. This phase serves as a feasibility study and is a prerequisite for advancing to subsequent phase. 12 healthy subjects will be enrolled in this study.
Device: Smart Mask V1 System
If the Non-Invasive (NI) phase demonstrates feasibility, the Invasive (IN) study will follow to validate the Smart Mask's measurements against a gold-standard method. This phase involves arterial blood gas analysis to directly measure arterial oxygen saturation (SaO2) using CO-oximetry. Participants undergo the same progressive hypoxia protocol within a controlled hypoxia room. An indwelling radial artery catheter is inserted to allow periodic arterial blood sampling at five predefined oxygen plateaus. The SaO2 values obtained from the CO-oximeter reference device (ABL90 FLEX) are then compared to the SpO2 values calculated by the Smart Mask. 24 healthy volunteers will be enrolled in this phase.
Device: Smart Mask V1 System
PPG-based sensors integrated into a PAP-compatible face mask to measure SpO2 and PR.
Also known as: Smart Mask, SMV1
SpO2 Accuracy (Arms)
Root mean square error (Arms) of SpO2 measured by the Smart Mask compared to SpO2 and SaO2 reference devices
Time frame: During each hypoxia session (90-140 minutes)
Plan to share: No — Data collected during the study will be specifically used to develop Smart Mask, a device intended to be commercialized by the study sponsor. Thus, there does not appear to be any value or reason to share IPD.
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Pathway Medtech, LLC.