Back to results

Nebula Study - Screener Apps and HSAT vs. PSG Comparison

Primary Purpose

Sleep Apnea, Obstructive

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PSG

Home Sleep Apnea Test with FDA cleared devices

Non-Contact Screening App

About this trial

This is an interventional screening trial for Sleep Apnea, Obstructive focused on measuring OSA, Sleep Apnea, OSA Screeners, Home Sleep Apnea Test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Clayton Sleep Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Concurrent PSG, HSAT, and Screener App Test

Arm Description

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

Outcomes

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.

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.

Full Information

NCT ID

NCT04597749

First Posted

August 31, 2020

Last Updated

February 1, 2021

Sponsor

ResMed

1. Study Identification

Unique Protocol Identification Number

NCT04597749

Brief Title

Nebula Study - Screener Apps and HSAT vs. PSG Comparison

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

October 27, 2020 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

January 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ResMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea, Obstructive

Keywords

OSA, Sleep Apnea, OSA Screeners, Home Sleep Apnea Test

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Concurrent PSG, HSAT, and Screener App Test

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

PSG

Intervention Description

In-lab sleep polysomnography test

Intervention Type

Diagnostic Test

Intervention Name(s)

Home Sleep Apnea Test with FDA cleared devices

Intervention Description

In-lab HST test

Intervention Type

Other

Intervention Name(s)

Non-Contact Screening App

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

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

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Clayton Sleep Institute

City

Maplewood

State/Province

Missouri

ZIP/Postal Code

63143

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Nebula Study - Screener Apps and HSAT vs. PSG Comparison

We'll reach out to this number within 24 hrs