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NCT04597749 Clinical Trial

Nebula Study - Screener Apps and HSAT vs. PSG Comparison

Sleep Apnea, Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04597749
Other study ID # SLP-20-06-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 27, 2020
Est. completion date January 20, 2021

Study information
Verified date February 2021
Source ResMed
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date January 20, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• PSG
In-lab sleep polysomnography 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.

Locations
Country Name City State
United States Clayton Sleep Institute Maplewood Missouri

Sponsors (1)
Lead Sponsor Collaborator
ResMed

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Day 1
Secondary OSA severity categories (normal, mild, moderate, severe) of Screnner apps and HSAT compared to PSG. Day 1
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