Nebula Study - Screener Apps and HSAT vs. PSG Comparison

Sponsor

ResMed (Industry)

Overall Status

Completed

CT.gov ID

NCT04597749

Collaborator

(none)

Enrollment

Location

Arm

2.8

Actual Duration (Months)

17.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive	Diagnostic Test: PSG Diagnostic Test: Home Sleep Apnea Test with FDA cleared devices Other: Non-Contact Screening App	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Nebula Study: Comparison of Sleep Screener Apps and Home Sleep Apnea Tests to Polysomnography

Actual Study Start Date :

Oct 27, 2020

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Jan 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Concurrent PSG, HSAT, and Screener App Test Participants will undergo a single night baseline PSG test with concurrent HSAT tests as well as non-contact screening mobile apps through a smartphone.	Diagnostic Test: PSG In-lab sleep polysomnography test Diagnostic Test: Home Sleep Apnea Test with FDA cleared devices In-lab HST test Other: Non-Contact Screening App Non-Contact Sleep Apnea Screening Applications at bedside table to assess for sleep apnea.

Arm

Intervention/Treatment

Experimental: Concurrent PSG, HSAT, and Screener App Test

Participants will undergo a single night baseline PSG test with concurrent HSAT tests as well as non-contact screening mobile apps through a smartphone.

Diagnostic Test: PSG

In-lab sleep polysomnography test

Diagnostic Test: Home Sleep Apnea Test with FDA cleared devices

In-lab HST test

Other: Non-Contact Screening App

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.