Status:
NOT_YET_RECRUITING
Detection of Sleep Stages and Arousals Using Neural Network Classifiers
Lead Sponsor:
Pathway Medtech, LLC.
Conditions:
Sleep Disordered Breathing (SDB)
Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this clinical study is to evaluate the accuracy of the Smart Mask V1 System (herein 'Smart Mask') in measuring sleep stages-Stage N1/N2, Stage N3, Rapid Eye Movement (herein 'REM'), a...
Detailed Description
CLINICAL APPROACH: To validate the SSAM's performance in determining sleep stages (N1/N2, N3, REM, Wake), arousals, and Arousal Index, two separate clinical studies are proposed. Both studies will use...
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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07136272
Start Date
September 1 2025
End Date
December 1 2025
Last Update
September 16 2025
Active Locations (3)
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1
Peninsula Sleep Center
Burlingame, California, United States, 94010
2
Amnova Research
Irvine, California, United States, 92604
3
ACTRI Center for Clinical Research
La Jolla, California, United States, 92093