Comparative Effectiveness Research to Enhance Outcomes in African-Americans With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Apnea Hypopnea Index (AHI)
研究概览
简要总结
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.
详细描述
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
- 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
- a) to compare diagnostic accuracy of home-based PM with laboratory-based PM
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female African-Americans (age ≥18 years)
- •Berlin Questionnaire
- •Ability to understand written and verbal English
排除标准
- •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
结局指标
主要结局
Apnea Hypopnea Index (AHI)
时间窗: 4 days
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).
次要结局
- Technical Failure Rate(4 days)
研究者
Bharati Prasad
Assistant Professor
University of Illinois at Chicago
