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

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.

Conditions

• Obstructive Sleep Apnea

Interventions

DEVICE

Portable monitoring

A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA.

OTHER

Polysomnography

One attended diagnostic sleep study.

DEVICE

Home portable monitoring

Portable monitoring with WP200 device - applied by participants once at home.

DEVICE

Laboratory portable monitoring

Portable monitoring with WP200 device - applied by technologist once in the laboratory simultaneously with polysomnography.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Illinois at Chicago

  lead OTHER

Principal Investigators

• Bharati Prasad, MD · University of Illinois at Chicago

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-08-31

Primary Completion

2012-04-30

Completion

2013-04-30

Countries

• United States

Study Locations