N/A
Completed N=75
Comparative Effectiveness Research to Enhance Outcomes in African-Americans With Obstructive Sleep Apnea
Source: ClinicalTrials.gov NCT01997723 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Apnea Hypopnea Index (AHI) — 30.3; 32.3; 39.1 events per hour
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea Hypopnea Index (AHI) |
30.3; 32.3; 39.1 | — |
| SECONDARY Technical Failure Rate |
5.3; 3.1 | — |
Eligibility Criteria
Inclusion Criteria
- Male and Female African-Americans (age ≥18 years)
- Berlin Questionnaire
- Ability to understand written and verbal English
Exclusion Criteria
- Past treatment of OSA (medical, dental, or surgical)
- Other primary sleep disorder(s) by history
- Active uncontrolled medical conditions/immobility
- Current drug or significant alcohol use
- No current residential address or contact phone number
Data sourced from ClinicalTrials.gov (NCT01997723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.