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
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

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