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).
Study 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.
Eligibility
Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* ≥ 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 Criteria:
* 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
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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