Nebula Study - Screener Apps and HSAT vs. PSG Comparison

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Diagnostic Test: PSG; Diagnostic Test: Home Sleep Apnea Test with FDA cleared devices; Other: Non-Contact Screening App

• Registration Number: NCT04597749
• Lead Sponsor: ResMed

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-22
• Study Start: 2020-10-27
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-20
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Concurrent PSG, HSAT, and Screener App Test	Non-Contact Screening App	Participants will undergo a single night baseline PSG test with concurrent HSAT tests as well as non-contact screening mobile apps through a smartphone.
Concurrent PSG, HSAT, and Screener App Test	Home Sleep Apnea Test with FDA cleared devices	Participants will undergo a single night baseline PSG test with concurrent HSAT tests as well as non-contact screening mobile apps through a smartphone.
Concurrent PSG, HSAT, and Screener App Test	PSG	Participants will undergo a single night baseline PSG test with concurrent HSAT tests as well as non-contact screening mobile apps through a smartphone.

Primary Outcome Measures

Name	Time	Method
AHI value. Clinical decision for treatment output (Y to CPAP or N to CPAP) of Screener apps and HSAT compared to PSG.	Day 1	The PSG clinical decision for treatment is defined as AHI≥15. Screener apps and HSATs provide AHI values that will be used for comparison.

Secondary Outcome Measures

Name	Time	Method
OSA severity categories (normal, mild, moderate, severe) of Screnner apps and HSAT compared to PSG.	Day 1

Trial Locations

Locations (1)

Clayton Sleep Institute; 🇺🇸 Maplewood, Missouri, United States