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Testing a home sleep test device for obstructive sleep apnea

Checks how well SleepView+ works at home for people with suspected sleep apnea.

Key facts

Who runs it
Beacon Biosignals
Where
Cleveland, Redwood City, Rochester, and San Antonio, United StatesSee the 4 sites
Trial code
Registry title
Validation and Usability Study of the SleepView+ Home Sleep Testing System for the Evaluation of Moderate to Severe Obstructive Sleep Apnea.
Status
Enrolling by invitation
People taking part
200 people, planned
Started
15 Feb 2026
Expected to end
15 Dec 2026
Type of study
Observational
Treatments tested
  • SleepView+
Record updated
17 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 12 and over who were sent to a sleep lab for an overnight sleep study. Many will have suspected obstructive sleep apnea, where breathing stops and starts during sleep.

Age
12 years and older
Sex
All sexes
Disease stage
Suspected obstructive sleep apnea needing an overnight sleep lab study. The trial focuses on suspected moderate to severe cases.

Main reasons for not taking part

  • Cannot read written instructions in English, has serious memory or thinking problems, or cannot give consent
  • Known to be pregnant when joining
  • Stroke or heart attack within 6 months of the sleep study
  • Taking part in another study that may affect the measurements
  • Other medical, legal or social issues the study team judges too risky or likely to affect use of the device

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • ≥ 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)

Who cannot take part

  • 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

Where in United States

  • West Region Sleep CenterCleveland, United StatesEnrolling by invitation
  • Redwood Pulmonary Medical AssociatesRedwood City, United StatesEnrolling by invitation
  • Sleep InsightsRochester, United StatesEnrolling by invitation
  • Sleep Therapy Research CenterSan Antonio, United StatesEnrolling by invitation

About the trial

What the trial wants to find out

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

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.

The group in the trial

  • Patients with suspected OSA

    All participants will have clinically suspected obstructive sleep apnea requiring PSG evaluation. The study population will be enriched for suspected moderate to severe obstructive sleep apnea. Participants must enroll prior to completion of their in lab PSG.

    Treatment: SleepView+

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
SleepView+ Validation Testing
Plain-language title
Testing a home sleep test device for obstructive sleep apneaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
17 March 2026