Sleep Apnea, Obstructive
Conditions
Keywords
treatment, positive airway pressure, compliance, cost effectiveness, clinical trial
Brief summary
This multi-site project compares compares the efficiency of a home-based portable monitoring strategy to a standard of care sleep laboratory-based strategy for the diagnosis and positive airway pressure treatment of obstructive sleep apnea in adults.
Detailed description
The study is a randomized, parallel group, unblinded, multicenter study that compares two approaches \[home-based, portable monitoring (PM) versus attended, laboratory-based polysomnography (PSG) (Lab)\] in adults, at least 18 years of age, with a moderate to high probability of obstructive sleep apnea (OSA) and who have been referred to sleep medicine specialists at AASM-accredited sleep centers for evaluation and/or management. The study is designed to compare the utility of the two approaches (PM group vs. Lab group) for the diagnosis and management of OSA in adults. Approximately 372 eligible adults will be randomized at screening to either the PM or Lab arm (186 per arm), undergo baseline OSA testing to confirm diagnosis and study eligibility, then receive positive airway pressure (PAP) titration studies to determine the level of pressure needed to treat their OSA. For qualifying participants, the titration study will be lab-based in the Lab group and be home-based using a commercially available portable, automatic PAP device (APAP) in the PM group. All qualifying study participants will have access to study CPAP equipment and supplies to treat their OSA. Primary outcomes (time from diagnosis to effective treatment, patient outcomes, and relative resource utilization) are determined at 1 and 3 months after starting CPAP treatment. Study participants who complete all of their study visits will keep their CPAP machine at the end of the study.
Interventions
OTHERPortable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex)
portable, home-based using the Embla Embletta X30 system as the diagnostic device and the Respironic REMStar Auto M series with CFlex as the PAP titration device.
laboratory-based testing
Sponsors
University Hospitals Cleveland Medical Center
The Cleveland Clinic
MetroHealth Medical Center
University of Washington
University of Minnesota
Northwestern University
University of Wisconsin, Madison
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Intermediate to high probability of having OSA based on an adjusted neck circumference \> 43 cm (17 inches) * Presence of excessive daytime sleepiness (Epworth sleepiness scale ≥ 12) Apnea-hypopnea index \>= 15 on diagnostic testing to continue in study
Exclusion criteria
* Severe chronic insomnia, other condition with \< 4 hrs of sleep per night * Unstable medical conditions * Major psychiatric diagnosis * Unable to undergo home testing * Concerns about unsafe driving * Severe COPD or restrictive lung disease * Chronic narcotic use * Alcohol abuse * History of cataplexy * Moderate to severe restless legs syndrome symptoms * Pre-existing diagnosis of sleep apnea * Prior experience with positive airway pressure treatment of sleep apnea * Anticipated upper airway surgery or gastric bypass surgery in 4 months * Decisional impairment for consenting * Hypoventilation syndrome, identified in the medical record * Waking oxygen saturation \< 92%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptance of CPAP treatment | from diagnosis to effective treatment |
Secondary
| Measure | Time frame |
|---|---|
| Compliance with CPAP therapy | 1 and 3 month post acceptance |
Countries
United States
Outcome results
None listed