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Validation and Usability Study of the SleepView+ Home Sleep Testing System for the Evaluation of Moderate to Severe Obstructive Sleep Apnea.
Sponsor: Beacon Biosignals
Summary
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.
Official title: SleepView+ Validation Testing
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2026-02-15
Completion Date
2026-12-15
Last Updated
2026-03-17
Healthy Volunteers
Yes
Conditions
Interventions
SleepView+
Participants will wear the SleepView+ sleep monitor during both their in lab overnight PSG (for validation of apnea and hypopnea detection versus gold-standard clinical in-lab PSG), and then subsequently at home (to assess device usability).
Locations (4)
Redwood Pulmonary Medical Associates
Redwood City, California, United States
Sleep Insights
Rochester, New York, United States
West Region Sleep Center
Cleveland, Ohio, United States
Sleep Therapy & Research Center
San Antonio, Texas, United States