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

NCT07476313 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-03-17

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Beacon Biosignals

    lead INDUSTRY

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-15
Primary Completion
2026-08-15
Completion
2026-12-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07476313 on ClinicalTrials.gov