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NCT07476313

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

Enrolling by Invitation
Not specifiedAges 12+Observational
Beacon Biosignals
~200 participants
Updated 2026-03-17 on ClinicalTrials.gov
What's tested:SleepView+

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnosis of moderate to severe obstructive sleep apnea (OSA)
Measured over 5 months

Conditions

Obstructive Sleep Apnea

Explore related trials

Obstructive Sleep Apnea

Where it's being run

4 sites across 4 states
California1
New York1
Ohio1
Texas1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

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

Age \<12 yrs
Participants who cannot read written instructions in English, have significant cognitive impairment or are otherwise unable to provide informed consent
Concomitant enrollment in another study protocol that may interfere with data acquisition or reliability of measurements
Known to be pregnant at time of recruitment
Stroke or myocardial infarction within 6 months sleep study
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.
Any other medical condition considered high risk or that may impact device usage, as determined by the site PI or medical monitor

What this trial measures

  • Diagnosis of moderate to severe obstructive sleep apnea (OSA)5 months

    SleepView+ derived apnea and hypopnea (over the total recording time) will be compared to in-lab PSG derived apnea and hypopnea count (over the total recording time) in order to determine the ability of the SleepView+ system to diagnose moderate to severe OSA. The primary endpoint will be positive percent agreement (PPA) and negative percent agreement (NPA) between SleepView+ diagnoses and in lab PSG. The passing criteria will be a lower bound of the 90% confidence interval of PPA exceeding 0.70 and a lower bound of the 90% confidence interval of NPA exceeding 0.70.