SSAMSmart Mask System for Sleep Disorder Detection in Sleep Apnea Patients
SSAM
+ Polysomnography
+ EnsoSleep
Apnea+5
+ Nervous System Diseases
+ Respiration Disorders
Supportive Care Study
Summary
Study start date: September 1, 2025
Actual 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
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
Amnova Research
Irvine, United StatesACTRI Center for Clinical Research
La Jolla, United States