150
Participants
Start Date
September 30, 2025
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
SSAM
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
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
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.
ACTRI Center for Clinical Research, La Jolla
Amnova Research, Irvine
Peninsula Sleep Center, Burlingame
Pathway Medtech, LLC.
INDUSTRY