NCT07476313

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

SleepView+ Validation Testing

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Beacon Biosignals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-02-15
• Primary completion: 2026-08-15
• Completion: 2026-12-15
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

4 sites across 1 country: United States