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

NCT07476313 | Enrolling By Invitation

• 1 other identifier: SV-2026
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

home sleep test

Outcome Measures

Primary Outcomes (1)

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

  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.

  5 months

Secondary Outcomes (3)

• Usability metrics

  5 months

• Diagnotic accuracy for mild OSA

  5 months

• Diagnostic accuracy for severe OSA

  5 months

Study Arms (1)

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.

Device: SleepView+

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).

Patients with suspected OSA

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults and children aged 12+ years with suspected OSA

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beacon Biosignals: lead

Study Sites (4)

Redwood Pulmonary Medical Associates

Redwood City, California, 94062, United States

Location

Sleep Insights

Rochester, New York, 14623, United States

Location

West Region Sleep Center

Cleveland, Ohio, 44135, United States

Location

Sleep Therapy & Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)