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SSAM

Smart Mask System for Sleep Disorder Detection in Sleep Apnea Patients

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What is being tested

SSAM

+ Polysomnography
+ EnsoSleep
Device
Diagnostic Test
Who is being recruted

Apnea
+5

+ Nervous System Diseases
+ Respiration Disorders
Over 18 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorPathway Medtech, LLC.
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2025Actual date on which the first participant was enrolled.

This clinical study aims to validate a new system called the Smart Mask V1 System (SSAM) designed to monitor sleep stages and disturbances. The study focuses on patients with sleep-disordered breathing conditions, such as central or obstructive sleep apnea, who require assistance from devices like CPAP or BiPAP. The Smart Mask system is being tested to ensure it provides accurate results that are comparable to traditional manual methods (known as polysomnography) and an existing automated system called EnsoSleep. The research hopes to demonstrate that SSAM can reliably detect different sleep stages and disturbances, potentially offering a more efficient way to monitor sleep quality and improve the management of sleep disorders. Participants in this study will undergo overnight sleep evaluations at one of three specialized sleep centers, where they will wear the Smart Mask along with their prescribed sleep therapy device. During the sleep study, various physiological signals such as brain activity, eye movements, and heart rate will be recorded using a combination of sensors. The Smart Mask will process these signals to determine sleep stages and disturbances, which will then be compared to results from standard manual evaluations. Additionally, the study will collect data to train and validate the Smart Mask's ability to classify sleep patterns, ensuring it meets necessary performance standards. This research will help determine if the Smart Mask can be a reliable tool for diagnosing and managing sleep-related conditions.

Official TitleValidation of Smart Mask V1 System: A Clinical Study Comparing a System for Detecting Sleep Stages and Arousals to Manual Polysomnography Scoring 
NCT07136272
Principal SponsorPathway Medtech, LLC.
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
150 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Apnea
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Apnea Syndromes
Sleep Wake Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Criteria

Inclusion Criteria: * 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 Criteria: * 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Participants in this arm will undergo a one-night, in-lab sleep study while wearing the Smart Mask and WatchPAT while receiving positive airway pressure ('PAP') therapy. Standard polysomnography ('PSG') data will be collected and stored. Three independent registered PSG technologists ('RPSGTs') will manually score the data to estimate sleep stages and arousals, following the guidelines in 'The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications', which is the definitive reference for the scoring of PSG and HSATs. PSG data will also be uploaded to EnsoSleep's cloud-based software system. Data from this phase will be used solely to train and refine the Smart Mask's neural network algorithms for detecting sleep stages and arousals. No algorithm validation will occur in this phase.

Embedded software featuring neural-network classifiers designed to detect and classify sleep stages (N1/N2, N3, REM, Wake), autonomic arousals, and an Arousal Index based on data (specifically instantaneous pulse rate and full-resolution flow waveforms) collected during PAP therapy.

Polysomnography (PSG) is an overnight, in-laboratory diagnostic procedure that records multiple physiological parameters during sleep. It typically includes monitoring of brain activity (EEG), eye movements (EOG), muscle activity (EMG), heart rhythm (ECG), respiratory effort, airflow, oxygen saturation, and body position. PSG is used to evaluate sleep architecture, identify sleep stages, detect arousals, and diagnose sleep disorders such as sleep apnea. The collected data are analyzed manually by trained sleep technologists following standardized scoring criteria.

EnsoSleep is software-only medical device intended for use by physicians to assess sleep quality and aid in the diagnosis of sleep disorders. The software analyzes physiological signals and automatically scores sleep study results, including respiratory, sleep staging, arousal and movement events. Automatically scored events and physiological signals are analyzed, displayed, and summarized for review by clinicians.
Group II
Experimental
Participants in this arm will undergo a single overnight, in-lab sleep study while wearing the Smart Mask and WatchPAT device, while receiving PAP therapy. Standard PSG data will be collected and stored. Data from the Smart Mask will be processed using trained neural networks to detect sleep stages (N1/N2, N3, REM, Wake), arousals, and calculate the Arousal Index. These outputs will be compared to: 1) manual scoring of PSG data by three independent, blinded RPSGTs; and 2) results from the predicate device, EnsoSleep. Data from this phase will be used validate the Smart Mask's neural network algorithms for detecting sleep stages and arousals.

Embedded software featuring neural-network classifiers designed to detect and classify sleep stages (N1/N2, N3, REM, Wake), autonomic arousals, and an Arousal Index based on data (specifically instantaneous pulse rate and full-resolution flow waveforms) collected during PAP therapy.

Polysomnography (PSG) is an overnight, in-laboratory diagnostic procedure that records multiple physiological parameters during sleep. It typically includes monitoring of brain activity (EEG), eye movements (EOG), muscle activity (EMG), heart rhythm (ECG), respiratory effort, airflow, oxygen saturation, and body position. PSG is used to evaluate sleep architecture, identify sleep stages, detect arousals, and diagnose sleep disorders such as sleep apnea. The collected data are analyzed manually by trained sleep technologists following standardized scoring criteria.

EnsoSleep is software-only medical device intended for use by physicians to assess sleep quality and aid in the diagnosis of sleep disorders. The software analyzes physiological signals and automatically scores sleep study results, including respiratory, sleep staging, arousal and movement events. Automatically scored events and physiological signals are analyzed, displayed, and summarized for review by clinicians.
Study Objectives
Primary Objectives

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 3 locations
Suspended
Peninsula Sleep CenterBurlingame, United StatesSee the location
Suspended
Amnova ResearchIrvine, United States
Suspended
ACTRI Center for Clinical ResearchLa Jolla, United States
Recruiting soon3 Study Centers