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

N/AEnrolling By InvitationNCT07476313

Beacon Biosignals200 enrolled

Overview

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.

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

200

Conditions

Obstructive Sleep Apnea

Interventions

Eligibility

Sex: ALLMin age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Redwood Pulmonary Medical Associates

Redwood City, California, United States

Sleep Insights

Rochester, New York, United States

West Region Sleep Center

Cleveland, Ohio, United States

Sleep Therapy & Research Center

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 5 months

Secondary Outcomes

Usability metrics

Summary statistics of data quality of Phase B (at home) recordings and usability survey responses will be used to assess device usability.

Time frame: 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.

Time frame: 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.

Time frame: 5 months