Validation and Usability Study of the SleepView+ Home Sleep Testing System for the Evaluation of Moderate to Severe Obstructive Sleep Apnea.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SleepView+.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SleepView+ Validation Testing
Overview
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.
Detailed description
This study is a validation and usability study of the SleepView+ home sleep test for assessing obstructive sleep apnea. The SleepView+ device consists of multiple peripheral sensors that are designed to be placed by patients themselves. The system is intended to be operable by patients without technologist intervention.
The study will first evaluate the ability of SleepView+ to diagnose moderate to severe obstructive sleep apnea, as compared to in lab polysomnography. In a second usability phase, participants will take the SleepView+ device home and record a second night without technologist or expert supervision/assistance. Usability surveys and data quality metrics will be collected to assess the ability of participants (or their caregivers) to successfully operate the device in its intended at-home use.
Interventions
- Device 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).
Primary outcome measures
- Diagnosis of moderate to severe obstructive sleep apnea (OSA) [Time frame: 5 months]
Secondary outcome measures (3)
- Usability metrics [Time frame: 5 months]
- Diagnotic accuracy for mild OSA [Time frame: 5 months]
- Diagnostic accuracy for severe OSA [Time frame: 5 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Ecologic or community
Study locations
United States · 4 centers
- Redwood Pulmonary Medical Associates — Redwood City
- Sleep Insights — Rochester
- West Region Sleep Center — Cleveland
- Sleep Therapy & Research Center — San Antonio
Identifiers
NCT: NCT07476313 · SV-2026