Smart mask could replace sleep lab tests for apnea patients

NCT ID NCT07136272

Not yet recruiting Diagnosis Sponsor: Pathway Medtech, LLC. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a smart mask that uses AI to detect sleep stages and breathing-related arousals in adults with sleep apnea. About 150 participants will wear the mask during an overnight sleep study, and its results will be compared to standard lab tests. If accurate, the mask could make sleep monitoring easier and more accessible.

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 device with embedded software that uses pulse rate and airflow data to detect sleep stages and arousals)
What this could lead to: If successful, this smart mask could offer a simpler, at-home way to monitor sleep quality and breathing problems without needing a full lab sleep study.
What could go wrong: This is an early validation study with only 150 people, so results may not apply to everyone. The device is not yet proven to be as accurate as standard sleep tests.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SLEEP APNEA SLEEP DISORDERED BREATHING (SDB)

Contacts and locations

Locations

ACTRI Center for Clinical Research

La Jolla, California, 92093, United States
Amnova Research

Irvine, California, 92604, United States
Peninsula Sleep Center

Burlingame, California, 94010, United States

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