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

Part of paid clinical trials in Redwood City, California.

Sponsor
Beacon Biosignals
Study ID
NCT07476313
Status
Enrolling By Invitation

Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • SleepView+ — DEVICE
    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 Details

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.

Key Dates

Start date
Feb 15, 2026
Status verified
Mar 2026
Primary completion
Aug 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Diagnosis of moderate to severe obstructive sleep apnea (OSA) [ Time Frame: 5 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Redwood Pulmonary Medical AssociatesRedwood CityCalifornia94062-
Sleep InsightsRochesterNew York14623-
West Region Sleep CenterClevelandOhio44135-
Sleep Therapy & Research CenterSan AntonioTexas78229-

Find similar trials in Redwood City, CA

By research site
Redwood Pulmonary Medical Associates· Redwood City, CASleep Insights· Rochester, NYWest Region Sleep Center· Cleveland, OHSleep Therapy & Research Center· San Antonio, TX

Related Studies