Portable Monitoring for Diagnosis and Management of Sleep Apnea

Study Overview
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Brief Summary
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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
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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.

Official Title
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Portable Monitoring in the Diagnosis and Management of Obstructive Sleep Apnea

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Other: Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex)
* Other: Standard polysomnography (PSG)


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>laboratory-based testing | Other: Standard polysomnography (PSG)<br>* laboratory-based testing<br>|
| Active Comparator: 2<br>home-based testing | Other: Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance of CPAP treatment |  | from diagnosis to effective treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with CPAP therapy |  | 1 and 3 month post acceptance | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment, positive airway pressure, compliance, cost effectiveness, clinical trial