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NCT07136272

Detection of Sleep Stages and Arousals Using Neural Network Classifiers

Not Yet Recruiting
NAAges 18+InterventionalSupportive care
Pathway Medtech, LLC.
~150 participants
Updated 2025-09-16 on ClinicalTrials.gov
What's tested:SSAMPolysomnographyEnsoSleep

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Agreement Between Smart Mask V1 System and EnsoSleep in Detecting Arousals and Arousal Index
Measured over One overnight sleep study session (6-8 hours per participant)

Conditions

Sleep Disordered Breathing (SDB)
Sleep Apnea

Where it's being run

3 sites across 1 states
California3

Who to contact

Mehran Farid-Moayer, M.D.
[email protected]
650-779-4055
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Eligibility criteria

Inclusion

Subjects must be at least 18 years of age at screening.
Subjects are individuals diagnosed with sleep-disordered breathing who have been prescribed PAP therapy or referred for a PSG.
Subjects must be willing and able to comply with the study requirements, which include using test, reference and predicate devices (if needed), completing training, interacting with study personnel and filling out questionnaires.
Subjects must be fluent in English.
Subject must be willing to undergo the screening and informed consent process prior to enrollment in the study.
Subjects must be deemed suitable candidates for this study based on the PI's evaluation of their condition and the features of the investigational device being tested.

Exclusion

Subjects unable or unwilling to wear a PAP mask as required for the study.
Subjects currently employed by, previously employed by or in any way affiliated (consulting, etc.) with any manufacturer or provider of PAP equipment and/or services.
Subjects who are pregnant.
Subjects with or requiring an implantable device, such as an electronic defibrillator, pacemaker, or other device.
Subjects considered by the PI to be medically unsuitable for study participation.

What this trial measures

  • Agreement Between Smart Mask V1 System and EnsoSleep in Detecting Arousals and Arousal IndexOne overnight sleep study session (6-8 hours per participant)

    This outcome is also based on a non-inferiority analysis, and assesses the agreement between the test device's measurements arousals and arousal index (number of arousals per hour of sleep) and those from PSG and EnsoSleep, a software system that automatically scores PSG data to determine these parameters. The study will be conducted similarly to that described above, substituting arousals and arousal index for the various sleep stages. The outcome for this comparison will be determined similarly to that described above using NA, PA, OA, and Evals 1 and 2 involving test, predicate, and reference devices. Secondary outcomes will be determined using more quantitative approaches (e.g., Bland-Altman and Deming regression plots) to determine errors between the test device and reference devices. For this analysis, the outcome will evaluate if relative errors for the test device's measurements of arousals and arousal indices are within clinically accepted ranges.