Nebula Study - Screener Apps and HSAT vs. PSG Comparison

ResMed50 enrolled

Overview

This is a prospective, unblinded, open-label, single group study. All subjects will undergo concurrent screener app, HSAT testing, and in-lab polysomnography.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Sleep Apnea, Obstructive

Interventions

PSGDIAGNOSTIC_TEST

In-lab sleep polysomnography test

Home Sleep Apnea Test with FDA cleared devicesDIAGNOSTIC_TEST

In-lab HST test

Non-Contact Screening AppOTHER

Non-Contact Sleep Apnea Screening Applications at bedside table to assess for sleep apnea.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participant is 18 years of age or older * Participant is willing to provide informed consent * Participant is willing to participate in all study related procedures Exclusion Criteria: * Unable to cease PAP therapy during PSG (if currently using) * Requires use of oxygen therapy during sleep * Diagnosis of untreated clinically relevant sleep disorder (other than SDB) * Pregnant * Participant is unsuitable to participate in the study in the opinion of the investigator * Participant has a permanent pacemaker, sustained non-sinus cardiac arrhythmias, and/or takes alpha blocker or short acting nitrate medication.

Locations (1)

Clayton Sleep Institute

Maplewood, Missouri, United States

Outcomes

Primary Outcomes

AHI value. Clinical decision for treatment output (Y to CPAP or N to CPAP) of Screener apps and HSAT compared to PSG.

The PSG clinical decision for treatment is defined as AHI≥15. Screener apps and HSATs provide AHI values that will be used for comparison.

Time frame: Day 1

Secondary Outcomes

OSA severity categories (normal, mild, moderate, severe) of Screnner apps and HSAT compared to PSG.

Time frame: Day 1

Data from ClinicalTrials.gov

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