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临床试验/NCT01096433
NCT01096433已完成不适用

Association of Circadian Variations,Sleep Architecture, Hypertension, and Prostaglandin in Sleep Apnea

Kyoto University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2010年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Prostaglandins in the urine and blood

研究概览

简要总结

The purpose of this study is to evaluate the associations of circadian variations, sleep architecture, hypertension and prostanoids in the patients with sleep apnea. In addition, the patients introduced to continuous positive airway pressure(CPAP) treatment, the effects of CPAP are also evaluated.

详细描述

Obstructive sleep apnea (OSA) is characterized by repetitive episodes of upper airway obstruction during sleep that provoke frequents arousals, sleep fragmentation, oxygen desaturation, and excessive daytime sleepiness. OSA may contribute to the development of systemic hypertension, cardiovascular disease. Many studies has reported a crucial role for the prostaglandin D system in sleep regulation. In addition, it has been described urinary or blood levels of prostaglandins was higher in the patients with hypertension, diabetes mellitus, and these values were associated with the severity of coronary artery disease. However, the relation between alterations of prostaglandin D system and sleep architecture, sleepiness, and clinical outcomes such as hypertension, arteriosclerosis in the patients with OSA are not known. Additionally, after CPAP treatment, we will investigate the association between change of prostaglandin system and sleep architecture, sleepiness, clinical outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.
  • Subjects diagnosed with OSA (apnea hypopnea index >=5/hour) by overnight polysomnography.

排除标准

  • Subjects treating for acute infections or malignancy.
  • Subjects with severe cardiovascular disease, diabetes,and renal failure.
  • 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

Prostaglandins in the urine and blood

时间窗: baseline, and 2days, 3 months after CPAP

次要结局

  • Clinical measurements (blood pressure, heart rate, sympathetic activity etc)(baseline, and 2days, 3 months after CPAP)
  • sleepiness and health-related quality of life(baseline, and 2days, 3 months after CPAP)
  • serum and urinary biomarker (inflammation, oxidative stress etc.)(baseline, and 2days, 3 months after CPAP)
  • endothelial function(baseline, and 2days, 3 months after CPAP)
  • polysomnography measurements(baseline, and 2days, 3 months after CPAP)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuichi Chihara

Medical doctor

Kyoto University

研究点 (1)

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