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Race And CPAP Effectiveness (RACE)

2020年10月28日 更新者:VA Office of Research and Development

Targeted Treatment of Obstructive Sleep Apnea to Reduce Cardiovascular Disparity

Obstructive sleep apnea (OSA) is a major public health problem in the U.S. and more than 35% of Veterans are at high risk for OSA. OSA is associated with progression of hypertension, an important health problem in Veterans. African Americans with OSA are at increased risk for poorly controlled hypertension and its health consequences. Implementing a care plan to increase the percentage of Veterans in whom blood pressure goals are achieved has been prioritized by Veterans Administration hospitals. Recent studies show that hypertension control can be improved with continuous positive airway pressure (CPAP) treatment of OSA. The aim of this proposal is to examine and compare the effects of CPAP treatment on 24-hour arterial blood pressure and central aortic blood pressure (measured non-invasively with a cuff on the upper arm) in African American and other Veterans.

研究概览

详细说明

Obstructive Sleep Apnea (OSA) and hypertension are both common and severe problems in African American individuals (as noted in the International Society on Hypertension in Blacks consensus statement). CPAP treatment of OSA is effective in controlling hypertension in patients with OSA, but has not been studied in African Americans, a high-risk population with potentially large health gains. This is an area of significance because poorly controlled hypertension leads to progression of cardiovascular disease (CVD) and morbidity in this population. By identifying CPAP treatment-response and relevant moderators of this response in African Americans with hypertension and OSA, targeted treatment of OSA can be implemented, reducing the excess burden of CVD. The investigators will determine the relative magnitude of hypertension response to CPAP treatment (ambulatory blood pressure and central aortic blood pressure) in 220 African American and Veterans of other race(s) with hypertension and newly diagnosed OSA (specific aim 1). The investigators will measure changes in pathogenic biomarkers (urinary cumulative sympathetic nervous system activity and oxidative stress) that are responsive to CPAP treatment in addition to hypertension assessments. Further, the investigators will examine the role of excessive daytime sleepiness (EDS), a potentially important moderator of treatment response, in these two patient populations (specific aim 2). Finally, the investigators will adjust the outcomes assessment for the anticipated biological heterogeneity among self-identified African Americans by measuring genetic ancestry (exploratory aim). This award will provide the foundation for the goals of this research program to reduce CVD disparity in diverse populations with targeted treatment of OSA.

研究类型

介入性

注册 (实际的)

220

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Illinois
      • Chicago、Illinois、美国、60612
        • Jesse Brown VA Medical Center, Chicago, IL

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 至 70年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Self-identified African American and other Veterans (of self-identified race other than African American)
  • Age: 30-70 years
  • Hypertension
  • Apnea hypopnea index (AHI) 15/hour on home sleep apnea test

Exclusion Criteria:

  • Past/current treatment of Obstructive Sleep Apnea or other primary sleep disorders
  • Active uncontrolled medical conditions
  • Shift work in past 6 months
  • Current drug use
  • Pregnancy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:单组作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:African Americans
138 Self identified African American
A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.
其他名称:
  • 呼吸机
有源比较器:non African Americans
53 Caucasians and 29 Other race (non African-Americans) Veterans.
A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.
其他名称:
  • 呼吸机

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
24 Hour Ambulatory Blood Pressure
大体时间:3 months

Mean systolic and diastolic blood pressure measured over 24 hours with ambulatory monitor (Spacelabs).

The change in blood pressure values were calculated as 3 months BP - baseline BP.

The mean and standard deviation in the sample are noted below.

3 months

次要结果测量

结果测量
措施说明
大体时间
Central Aortic Blood Pressure
大体时间:3 months

Central aortic blood pressure (CABP) measured noninvasively with a cuff (SphygmoCor XCEL).

The change in CABP values were calculated as 3 months CABP - baseline CABP. The mean and standard deviation in the sample are noted below.

3 months
Urinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane)
大体时间:3 months

Urine samples from participants over 24 hours will be analyzed for catecholamines and overnight sample will be partitioned for measurement of oxidative stress.

The change in urine catecholamine values were calculated as 3 months - baseline.

The mean and standard deviation in the sample are noted below.

3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Bharati Prasad, MD、Jesse Brown VA Medical Center, Chicago, IL

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年1月5日

初级完成 (实际的)

2019年8月30日

研究完成 (实际的)

2019年8月30日

研究注册日期

首次提交

2013年9月9日

首先提交符合 QC 标准的

2013年10月8日

首次发布 (估计)

2013年10月10日

研究记录更新

最后更新发布 (实际的)

2020年11月20日

上次提交的符合 QC 标准的更新

2020年10月28日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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