Long-term Effects of CPAP on Lipidemia and Hs-CRP Levels in OSA Patients
2014年4月28日 更新者:Chinese Pulmonary Vascular Disease Research Group
Long-term Effects of Continuous Positive Airway Pressure on Lipidemia and High-sensitivity C-reactive Protein Levels in Nonobese Patients With Coronary Heart Disease and Obstructive Sleep Apnea
The increased risk of atherosclerotic morbidity and mortality in patients with obstructive sleep apnea (OSA) has been linked to hypertension, insulin resistance, dyslipidemia, and systemic inflammation.
The relationship regarding obstructive sleep apnea (OSA) and lipidemia and systemic inflammation is far from conclusion for obesity as a strong confounding factor.
研究概览
详细说明
Obstructive sleep apnea (OSA) is a common sleep disorder characterized by recurrent episodes of partial or complete obstruction of the upper airway during sleep, resulting in sleep fragmentation and oxyhemoglobin desaturation.
OSA is recognized as an important public health problem in developed country, affecting 9 and 24% of middle-aged females and males, respectively.
OSA, however, is not recognized as an abnormality for the majority and doesn't get more attention from most people in China.
Increasing evidence now indicates that severe OSA is associated with increased cardiovascular morbidity and mortality, mainly due to acute myocardial infarction and stroke.
Atherosclerosis is a key mechanism for these cardiovascular events.
Numerous studies have explored the relationship between hypertension and OSA.
And these studies confirms that OSA is an important identifiable cause of hypertension and a raised blood pressure has been shown to fall with effective continuous positive airway pressure (CPAP) treatment.
Dyslipidemia, an established independent risk factor for coronary heart disease (CHD) and atherosclerosis, is common in patients with OSA.
But there are limited interventional data on OSA and lipidemia, showing controversial results.
Several studies9,10 have shown a direct relationship between OSA and lipid profiles, independently of obesity, while other studies have demonstrated that obesity, as a confounding factor, contributed to dyslipidemia among OSA patients.11,12
Taken together, adiposity is a strong confounding factor for interpretation of the causal relationship between dyslipidemia and OSA.
Few studies have focused on nonobese patients.10,13
There are only a small number of randomized trials that have examined the effect of CPAP on fasting lipid profiles14,15 and none were specifically designed to evaluate the lipid profiles.
Furthermore, most studies assessed the impact of CPAP on OSA-related lipids without statin therapy.
In this way, it may be useful to avoid the disturb conditions due to statin treatment.
But it is impractical to those patients with OSA and CHD.
Since statins, in addition to decreasing hyperlipidemia levels, also inhibit inflammatory cytokines and play a critical role of plaque stabilization in CHD patients.
Similarly, the condition existed in the examination of high-sensitivity C-reactive protein (hs-CRP) in CHD subjects with OSA.
Therefore, the aims of the present study were (1) to establish whether CPAP therapy decreases lipid profiles and hs-CRP levels in nonobese patients with CHD and OSA, (2) to establish whether a relationship exists between the severity of OSA and levels of these circulating markers, and (3) to demonstrate a possible mechanism for the prevention of cardiovascular disease.
研究类型
介入性
注册 (实际的)
78
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
-
-
-
Beijing、中国、100037
- Center of pulmonary vascular disease, Fuwai hospital
-
-
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
45年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Participants diagnosed with a confirmation of CHD and moderate to severe
Exclusion Criteria:
- A body mass index (BMI) ≥ 25 kg/m2
- Established hypertension, diabetes mellitus, predominantly central sleep apnea, hypothyroidism
- A history of smoking, chronic obstructive pulmonary disease, atopy, rhinitis, arthritis
- Pharmacological treatment that could affect lipids and hs-CRP levels
- Epworth Sleepiness Scale (ESS) ≥15
- Diagnosed with malignant cancer with a life expectancy of less than 1 years
- Severe psychiatric disease, sustained excessive alcohol use, New York Heart Association Class III-IV degree
- Declined to participate or were unable to give informed consent.
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:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Cpap
|
CPAP group received fixed-level CPAP titration using an automated pressure setting device for one night.
The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night, according to a previous validation by our study.
其他名称:
|
|
无干预:No Cpap
|
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 |
|---|---|---|
|
lipid profiles
大体时间:baseline, Change from baseline lipids at 6 months,Change from baseline lipids at 12 months
|
plasma fasting lipid profiles were measured at baseline, 6months,and 12months.
|
baseline, Change from baseline lipids at 6 months,Change from baseline lipids at 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
High-sensitivity C-reactive protein
大体时间:baseline,Change from baseline high-sensitivity C-reactive protein at 6 months,Change from baseline high-sensitivity C-reactive protein at 12 months
|
Fasting plasma high-sensitivity C-reactive protein was analyzed at baseline,6 months,and 12 months.
|
baseline,Change from baseline high-sensitivity C-reactive protein at 6 months,Change from baseline high-sensitivity C-reactive protein at 12 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。
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
2010年1月1日
初级完成 (实际的)
2013年12月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2014年4月24日
首先提交符合 QC 标准的
2014年4月28日
首次发布 (估计)
2014年4月30日
研究记录更新
最后更新发布 (估计)
2014年4月30日
上次提交的符合 QC 标准的更新
2014年4月28日
最后验证
2014年4月1日
更多信息
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.