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

SleepView+ Validation Testing

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: SleepView+

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94062
      • Redwood Pulmonary Medical Associates
  • New York
    • Rochester, New York, United States, 14623
      • Sleep Insights
  • Ohio
    • Cleveland, Ohio, United States, 44135
      • West Region Sleep Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • Sleep Therapy & Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults and children aged 12+ years with suspected OSA

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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+; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability metrics	Summary statistics of data quality of Phase B (at home) recordings and usability survey responses will be used to assess device usability.	5 months
Diagnotic accuracy for mild OSA	Subgroup analysis will be performed on participants diagnosed with mild OSA (Apnea-Hypopnea Index of 5-15). Identical non-inferiority analyses will be conducted on the apnea and hypopnea indices from SleepView+ as compared to in-lab PSG in this cohort.	5 months
Diagnostic accuracy for severe OSA	Subgroup analysis will be performed on participants diagnosed with severe OSA (Apnea-Hypopnea Index of >30). Identical non-inferiority analyses will be conducted on the apnea and hypopnea indices from SleepView+ as compared to in-lab PSG in this cohort.	5 months

Collaborators and Investigators

• Sponsor: Beacon Biosignals

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: home sleep test
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: SV-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No