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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: Completed NA study, sponsored by University of Illinois at Chicago.
NCT01997723 is a NA study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 75 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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).
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 |
What the finished NCT01997723 record still lists
NCT01997723 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Polysomnography is the first listed.
NCT01997723 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01997723's enrollment target sits among peer trials
75 1069th of 2000 higher than 919 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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