NCT01997723

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-04-01
• Completion: 2013-04-01
• First posted: 2013-11-28
• Last updated: 2024-05-29
• Results posted: 2014-06-20

Locations

1 site across 1 country: United States