Comparative Effectiveness Research to Enhance Outcomes in African-Americans With Obstructive Sleep Apnea

Study Overview
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Brief Summary
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Obstructive Sleep Apnea (OSA) is under-diagnosed and is associated with increased cardiovascular morbidity and mortality. Laboratory-based overnight polysomnography (PSG) is the gold standard in clinical practice to diagnose OSA but has availability, cost, and resource limitations. In the last decade, an alternative diagnostic strategy, Portable Monitoring (PM) has emerged with the goal of reducing expense and delays in clinical management. In contrast to PSG, PM maybe performed unattended in homes, utilize different neurophysiologic and cardiorespiratory parameters, and may synthesize these data differently. PM is feasible and is approved by Centers for Medicare and Medicaid Services (CMS) in the United States. However, the diagnostic utility of PM in minority and underserved populations is not defined. African-Americans are more severely affected by hypertension and cardiovascular disease (CVD) than other ethnic groups and OSA is more common in this population. OSA is a treatable cause of hypertension. Despite this the impact of timely interventions for OSA on health outcomes and risk reduction specific to African Americans is unknown. Purpose of this research: In view of the vulnerability of this population and the potential for improvement in healthcare access for OSA with home-based diagnosis, this study aims to establish the feasibility and identify the potential advantages and limitations of home-based diagnosis of OSA in a high-risk urban African-American population including veterans with frequently limited access to healthcare. Hypothesis: The investigators hypothesize that home-based PM is not inferior to standard laboratory-based PSG in effectively diagnosing OSA in urban African Americans.

Detailed Description
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Hypothesis: The investigators hypothesize that home-based PM is not inferior to standard laboratory-based PSG in effectively diagnosing OSA in urban African Americans. The specific aims of this project are: Primary Aims: Aim 1. To compare the validity of a comprehensive and current PM technology to standard in-laboratory full PSG 1a) to measure and compare diagnostic accuracy of home-based PM with laboratory-PSG b) to measure and compare diagnostic accuracy of simultaneous laboratory-based PM with laboratory-PSG Aim 2. To test the reliability and examine the applicability of PM in the home-setting a) to compare diagnostic accuracy of home-based PM with laboratory-based PM 2b) to examine factors associated with technical reliability (data failure rate) of home-based PM 2c) to compare patient satisfaction and preference of testing in home-setting to laboratory-setting

Official Title
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Comparative Effectiveness Research to Enhance Outcomes in African-Americans With Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Portable monitoring
* Other: Polysomnography
* Device: Home portable monitoring
* Device: Laboratory portable monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female African-Americans (age ≥18 years) Berlin Questionnaire Ability to understand written and verbal English Exclusion Criteria: Past treatment of OSA (medical, dental, or surgical) Other primary sleep disorder(s) by history Active uncontrolled medical conditions/immobility Current drug or significant alcohol use No current residential address or contact phone number

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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OSA testing<br>Cross-over design, single group/arm Interventions: polysomnography with simultaneous portable monitoring and home portable monitoring administered to each participant in random order. | Device: Portable monitoring<br>* A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA.<br>* Other names: WatchPAT200, Itamar medical Inc.;Other: Polysomnography<br>* One attended diagnostic sleep study.<br>Device: Home portable monitoring<br>* Portable monitoring with WP200 device - applied by participants once at home.<br>Device: Laboratory portable monitoring<br>* Portable monitoring with WP200 device - applied by technologist once in the laboratory simultaneously with polysomnography.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index (AHI) | AHI is the number of abnormal respiratory events (apneas and hypopneas) per hour of sleep. AHI on home portable monitor (PM) compared to AHI on laboratory polysomnography (PSG). | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Failure Rate | home PM tests that failed to provide technically adequate data for diagnosis. Technical failure(s) were tests where estimated total sleep time (TST) was ≤ 2 hours or portable monitor data of interpretable quality was less than 4 hours per recording. | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA, portable monitoring, home diagnosis