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

Not Applicable

Completed

Conditions: Obstructive Sleep Apnea

Interventions: Device: Portable monitoring
Other: Polysomnography
Device: Home portable monitoring
Device: Laboratory portable monitoring

Registration Number: NCT01997723

Lead Sponsor: University of Illinois at Chicago

Brief Summary: 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: 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

1. 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

2. 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 75

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OSA testing	Polysomnography	Cross-over design, single group/arm Interventions: polysomnography with simultaneous portable monitoring and home portable monitoring administered to each participant in random order.
OSA testing	Home portable monitoring	Cross-over design, single group/arm Interventions: polysomnography with simultaneous portable monitoring and home portable monitoring administered to each participant in random order.
OSA testing	Portable monitoring	Cross-over design, single group/arm Interventions: polysomnography with simultaneous portable monitoring and home portable monitoring administered to each participant in random order.
OSA testing	Laboratory portable monitoring	Cross-over design, single group/arm Interventions: polysomnography with simultaneous portable monitoring and home portable monitoring administered to each participant in random order.

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index (AHI)	4 days	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).

Secondary Outcome Measures

Name	Time	Method
Technical Failure Rate	4 days	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.