Nebula Study: Comparison of Sleep Screener Apps and Home Sleep Apnea Tests to Polysomnography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- AHI value. Clinical decision for treatment output (Y to CPAP or N to CPAP) of Screener apps and HSAT compared to PSG.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
- •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.
Arms & Interventions
Concurrent PSG, HSAT, and Screener App Test
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: PSG (Diagnostic Test)
Concurrent PSG, HSAT, and Screener App Test
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: Home Sleep Apnea Test with FDA cleared devices (Diagnostic Test)
Concurrent PSG, HSAT, and Screener App Test
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: Non-Contact Screening App (Other)
Outcomes
Primary Outcomes
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
- OSA severity categories (normal, mild, moderate, severe) of Screnner apps and HSAT compared to PSG.(Day 1)