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临床试验/NCT00635674
NCT00635674已完成不适用

Effects of CPAP on Cardiovascular Risk Profile in Patients With Severe Obstructive Sleep Apnea and Metabolic Syndrome

Pavol Jozef Safarik University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2007年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
Cardiovascular disease risk profile (as assessed using the multivariable risk factor algorithm)

研究概览

简要总结

The increased risk of atherosclerotic morbidity and mortality in patients with obstructive sleep apnea (OSA) has been linked to arterial hypertension, insulin resistance, systemic inflammation, and oxidative stress in previous studies.

We aimed to determine the effects of 8-weeks therapy with continuous positive airway pressure (CPAP) on glucose and lipid profile, systemic inflammation, oxidative stress, and the global cardiovascular disease (CVD) risk in patients with severe OSA and metabolic syndrome.

详细描述

Patients with obstructive sleep apnea (OSA) are at increased risk of atherosclerotic morbidity and mortality.OSA is associated with the development and/or worsening of arterial hypertension, a traditional risk factor of atherosclerosis.Moreover, OSA has been linked to novel factors related to atherogenesis - metabolic syndrome,systemic inflammation,6 and oxidative stress.

Numerous studies have selectively examined the effects of continuous positive airway pressure (CPAP) ventilation, the primary treatment for OSA, on the traditional and novel risk factors of atherosclerosis. A recent metaanalysis of 16 randomized trials indicated that CPAP decreases blood pressure in patients with OSA.9 Furthermore, reductions in serum total cholesterol, C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin (IL)-6 and IL-8 were demonstrated after effective CPAP therapy.In addition, CPAP was shown to reduce systemic oxidative stress.Improvements in insulin sensitivity have been reported in some,but not in all studies. Importantly, substantial evidence links the effects of CPAP to compliance with this treatment.

Most observational studies examined the effects of CPAP across a broad-range of OSA severity, and have included patients with and without the metabolic syndrome. Up to now, no study analyzed the effects of CPAP on glucose and lipid metabolism, systemic inflammation, oxidative stress, and the global cardiovascular disease (CVD) risk within the same cohort of subjects with severe OSA and concurrent metabolic syndrome. Importantly, the metabolic syndrome exacerbates CVD risk over and above that attributable to OSA alone. Therefore, reduction of CVD risk in patients with OSA and concurrent metabolic syndrome is of paramount importance.

The primary purpose of the present study was to determine, in patients with severe OSA and metabolic syndrome compliant to CPAP, the effects of 8-weeks therapy on the glucose and lipid profile, systemic inflammation, oxidative stress, and on the global CVD risk. The secondary goal was to analyze factors related to compliance with CPAP.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •severe OSA (more than 30 obstructive apneas or hypopneas per hour of sleep and excessive daytime sleepiness)
  • •metabolic syndrome

排除标准

  • •endocrine or metabolic disorders other than metabolic syndrome
  • •history of myocardial infarction, angina or stroke
  • •inflammatory or other chronic disease
  • •respiratory disorder other than OSA
  • •neurological lesions
  • •regular use of sedative medication or alcohol

研究组 & 干预措施

Group I - compliant

Experimental

CPAP use for more than 4 hr/night

干预措施: CPAP device - REMstar Plus, Respironics, Murrysville, USA (Device)

Group 2-noncompliant

Active Comparator

CPAP for less than 4 hr/night

干预措施: CPAP device - REMstar Plus, Respironics, Murrysville, USA (Device)

结局指标

主要结局

Cardiovascular disease risk profile (as assessed using the multivariable risk factor algorithm)

时间窗: 8 weeks therapy with Continuous positive airway pressure

次要结局

  • insulin sensitivity(8 weeks)

研究者

发起方
Pavol Jozef Safarik University
申办方类型
Other

研究点 (1)

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