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Completed

NCT Number: NCT04597749

Nebula Study - Screener Apps and HSAT vs. PSG Comparison

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

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clayton Sleep Institute

Maplewood, Missouri, 63143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PSG

Diagnostic Test

In-lab sleep polysomnography test

Home Sleep Apnea Test with FDA cleared devices

Diagnostic Test

In-lab HST test

Non-Contact Screening App

Other

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

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Oct 22, 2020
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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