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临床试验/NCT01015872
NCT01015872已完成不适用

The Investigation of the Roles of Prostanoids in Patients With Sleep Apnea Syndrome

Kyoto University, Graduate School of Medicine2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2009年12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
46
试验地点
2
主要终点
metabolites of arachidonic acid in the urine and blood

研究概览

简要总结

The purpose of this study is to evaluate the relationships between prostanoids and various outcomes such as sleep disturbance, hypertension and arteriosclerosis in patients with sleep apnea syndrome(SAS). In the patients introduced to continuous positive airway pressure(CPAP) treatment, the effects of CPAP are also evaluated.

详细描述

SAS is characterized by abnormality during sleep and hypoxemia from apnea and hypopnea, followed by systemic inflammation and organ dysfunction like cardiovascular diseases. Systemic inflammation causes the activation of arachidonic acid metabolism, producing prostaglandins (PGs) and leukotrienes (LTs). In addition, significant relationships between PGD2 and PGE2 and sleep, PGF2α and hypertension, PGI2 and thromboxane and platelet aggregation and so on are reported. Therefore, it is hypothesized that many prostanoids affect the pathophysiology of SAS. However, the relationships between prostanoids and clinical outcomes in patients with SAS are unknown. Although CPAP is the major treatment of SAS, the effects of CPAP on prostanoids are not known, either. Thus, the purpose of this study is to evaluate those relationships.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects hospitalized in Kyoto University Hospital for careful examination of SAS

排除标准

  • Subjects with severe respiratory diseases, severe heart diseases, severe vascular diseases, or severe diabetes mellitus.
  • Subjects taking nonsteroidal anti-inflammatory drugs, steroids or immunosuppressants.

研究组 & 干预措施

CPAP

Experimental

the subjects introduced with CPAP treatment

干预措施: CPAP treatment (Device)

结局指标

主要结局

metabolites of arachidonic acid in the urine and blood

时间窗: 3 months

次要结局

  • Polysomnography measurements(3 months)
  • Sleepiness and health-related quality of life(3 months)
  • Blood pressure and pulse rate(3 months)
  • Endothelial dysfunction(3 months)
  • Platelet aggregation(3 months)
  • Cardiac and neck echo cardiography(3 months)

研究者

发起方
Kyoto University, Graduate School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Toru Oga

Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine

Kyoto University, Graduate School of Medicine

研究点 (2)

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