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NCT01997723 · ClinicalTrials.gov registry record · NA
Comparative Effectiveness Research to Enhance Outcomes in African-Americans With Obstructive Sleep Apnea
A NA study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- NA
- Development phase
- 75
- Enrollment target
NCT01997723 is a NA study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 75 participants.
The verdict
NCT01997723, a NA study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
Study 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.
Interventions
- OTHER Polysomnography
- DEVICE Portable monitoring
- DEVICE Home portable monitoring
- DEVICE Laboratory portable monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01997723
The ClinicalTrials.gov registry entry for NCT01997723 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Polysomnography is the first listed.
NCT01997723 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01997723 about?
NCT01997723 is a clinical study titled "Comparative Effectiveness Research to Enhance Outcomes in African-Americans With Obstructive Sleep Apnea". 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 decad...
What is the current status of trial NCT01997723?
This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2011-08. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01997723?
The interventions under investigation include: Polysomnography (OTHER), Portable monitoring (DEVICE), Home portable monitoring (DEVICE), Laboratory portable monitoring (DEVICE).
Who is sponsoring clinical trial NCT01997723?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
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