Detection of Sleep Stages and Arousals Using Neural Network Classifiers

NANot yet recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Sleep Disordered Breathing (SDB)Sleep Apnea
Interventions
DEVICE

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.

DIAGNOSTIC_TEST

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.

DEVICE

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.

Trial Locations (3)

92093

ACTRI Center for Clinical Research, La Jolla

92604

Amnova Research, Irvine

94010

Peninsula Sleep Center, Burlingame

All Listed Sponsors
lead

Pathway Medtech, LLC.

INDUSTRY