Validation and Usability Study of the SleepView+ Home Sleep Testing System for the Evaluation of Moderate to Severe Obstructive Sleep Apnea.
Key facts
- Where
- Cleveland, Redwood City, Rochester, and San Antonio, United StatesSee the 4 sites
Where in United States
- West Region Sleep CenterCleveland, United StatesNo longer taking part
- Redwood Pulmonary Medical AssociatesRedwood City, United StatesNo longer taking part
- Sleep InsightsRochester, United StatesNo longer taking part
- Sleep Therapy Research CenterSan Antonio, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Beacon Biosignals
- Trial code
- NCT07476313
- Record updated
- 17 March 2026
- Original description
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).Read full original descriptionShow less
SleepView+ Validation Testing
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.
Inclusion: ≥ 12 years of age; Referred to a sleep lab study site with a clinical indication for an overnight PSG (either full-night or split-night PSG/PAP titration sleep study).
Exclusion: Concomitant enrollment in another study protocol that may interfere with data acquisition or reliability of measurements; Participants who cannot read written instructions in English, have significant cognitive impairment or are otherwise unable to provide informed consent; Stroke or myocardial infarction within 6 months sleep study; Any other medical condition considered high risk or that may impact device usage, as determined by the site PI or medical monitor; Age <12 yrs; Known to be pregnant at time of recruitment; Deemed unsuitable for selection by the research team or medical team due to any medical, legal, social, or interpersonal issues, that would either compromise the study or the routine care of patients.