Nebula Study - Screener Apps and HSAT vs. PSG Comparison
Not Applicable
Completed
- Conditions
- Sleep Apnea, Obstructive
- Registration Number
- NCT04597749
- Lead Sponsor
- ResMed
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method OSA severity categories (normal, mild, moderate, severe) of Screnner apps and HSAT compared to PSG. Day 1
Trial Locations
- Locations (1)
Clayton Sleep Institute
🇺🇸Maplewood, Missouri, United States
Clayton Sleep Institute🇺🇸Maplewood, Missouri, United States