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

Sponsor
Pathway Medtech, LLC.
Study ID
NCT07086742
Status
Recruiting
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Conditions

  • Sleep Apnea
  • Sleep Quality
  • Sleep-disordered Breathing (SDB)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Smart Mask V1 System — DEVICE
    PPG-based sensors integrated into a PAP-compatible face mask to measure SpO2 and PR.

Study Details

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 Dates

First listed
Jul 25, 2025
Start date
Sep 1, 2025
Status verified
Jun 2025
Primary completion
Dec 15, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Non-Invasive (NI)
    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.
  • Experimental: Invasive (IN)
    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.

Primary Outcome Measure

SpO2 Accuracy (Arms) [ Time Frame: During each hypoxia session (90-140 minutes) ]

Central Contacts

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