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临床试验/NCT01365832
NCT01365832已完成不适用

CRP Evolution Pattern in CPAP Treated Obstructive Sleep Apnea Patients. Does Gender Play a Role?

University of Crete2 个研究点 分布在 1 个国家目标入组 436 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
436
试验地点
2
主要终点
Change in CRP in OSA patients, according to gender, 3 and 6 months after the start of effective CPAP treatment.

研究概览

简要总结

C-reactive protein (CRP) is directly implicated in atherogenesis and associated cardiovascular morbidity in patients with obstructive sleep apnea (OSA). Effective Continuous Positive Airway Pressure (CPAP) treatment has been shown to gradually decrease CRP levels and thus consequently improve disease-related cardiovascular morbidity. However, the influence of gender on the CRP evolution pattern has never been assessed before. The aim of our study was to investigate possible gender differences in CRP evolution in OSA patients 3 and 6 months after the start of effective CPAP treatment.

详细描述

OSA is an independent risk factor for a number of cardiovascular diseases. One important possible mechanism underlying cardiovascular disease in patients with OSA is systemic inflammation. CRP, an acute phase reactant secreted by the liver, is one of the most actively studied biomarkers of low-grade inflammation, and numerous studies have shown that higher CRP levels are associated with high mortality and morbidity due to cardiovascular disease in men and women. In patients with OSA, the question as to whether or not CRP levels are elevated is still under debate. Although continuous positive airway pressure (CPAP) is effective in the management of OSA, conflicting data also exist regarding the effects of CPAP on CRP levels. However, none of the existing studies assessed the influence of gender on the CRP evolution pattern. Therefore, the aim of this study was to investigate possible gender differences in CRP evolution in patients with moderate to severe OSA, free of medical comorbidities, 3 and 6 months after the start of effective CPAP treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with apnoea-hypopnoea index >15/h

排除标准

  • chronic obstructive pulmonary disease
  • diabetes mellitus
  • coronary artery disease
  • congestive heart failure
  • chronic renal failure
  • known dyslipidemia
  • smoking history
  • hypothyroidism
  • chronic or recent infectious or inflammatory disease
  • use of anti-inflammatory or antibiotic drugs, or statins.
  • postmenopausal females on estrogen replacement therapy.

结局指标

主要结局

Change in CRP in OSA patients, according to gender, 3 and 6 months after the start of effective CPAP treatment.

时间窗: Day 1, Month 3 and Month 6 post treatment

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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