Validation and Usability Study of the SleepView+ Home Sleep Testing System for the Evaluation of Moderate to Severe Obstructive Sleep Apnea.

The goal of this observational study is to characterize the performance of the SleepView+ home sleep test system for the evaluation of moderate to severe obstructuve sleep apnea (OSA) in adult and pediatric patients (ages 12 and over). This study is being conducted in patients being evaluated for a sleep disorder who are scheduled to undergo an in lab polysomnigraphic study (PSG), enriching for suspected obstructive sleep apnea. This study will involve two phases: A - comparison of SleepView+ detection of apneas and hypopneas to simultaneously collected in lab PSG (validation phase) and B - evaluation of the ability of patients to use the SleepView+ system in their home environment without sleep technologist support (usability phase) Participants will progress from phase A to phase B.

NCT Number	NCT07476313
Lead Sponsor	Beacon Biosignals
Conditions	Obstructive Sleep Apnea
Enrollment	200 participants
Start Date	2026-02-15
Primary Completion	2026-08-15 (estimated)
Study Completion	2026-12-15 (estimated)
Updated on ClinicalTrials.gov	2026-03-17