Sleep Apnea, Obstructive
Conditions
Keywords
OSA, Sleep Apnea, OSA Screeners, Home Sleep Apnea Test
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.
Interventions
DIAGNOSTIC_TESTPSG
In-lab sleep polysomnography test
DIAGNOSTIC_TESTHome Sleep Apnea Test with FDA cleared devices
In-lab HST test
OTHERNon-Contact Screening App
Non-Contact Sleep Apnea Screening Applications at bedside table to assess for sleep apnea.
Sponsors
ResMed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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) * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| OSA severity categories (normal, mild, moderate, severe) of Screnner apps and HSAT compared to PSG. | Day 1 |
Countries
United States
Outcome results
None listed