CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
Portable monitoring +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01997723
NCT01997723N/ACompleted

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

University of Illinois at Chicago·interventional·Posted Nov 28, 2013·Updated May 29, 2024

In Brief

A clinical study evaluating Portable monitoring, Polysomnography, and 2 other interventions for Obstructive Sleep Apnea. Completed, enrolled 75 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 28, 2013
Enrollment StartAug 1, 2011
Primary CompletionApr 1, 2012
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.6 years ago

Interventions

Portable monitoringdevice

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

Polysomnographyother

One attended diagnostic sleep study.

Home portable monitoringdevice

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

Laboratory portable monitoringdevice

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