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临床试验/NCT00832468
NCT00832468已完成2 期

The Complementary Effect of Ear Acupressure on Older Patients With Chronic Insomnia and Anxiety

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
72
试验地点
2
主要终点
polysomnography

研究概览

简要总结

Ear acupressure is commonly applied to treat insomnia in Oriental clinical practice but lacking the evidence of the randomized controlled trial (RCT)of ear acupressure on insomnia. In this study, a RCT is conducted to investigate the complementary effect of ear acupressure on chronic insomnia in old adults.

详细描述

Even though there have been many advances in the pharmacological treatment of insomnia, many patients with insomnia visit complementary and alternative medicine (CAM) specialists for help due to fear of the side effects of long-term treatment with hypnotics. Acupuncture is commonly used to treat insomnia in the field of CAM. Among the different methods of acupuncture, it has been noted that ear acupressure (placing magnetic pellets on the auricular points), which has the advantage of being non-invasive and easily carried out, shows possible effects whereby there is improvement in the sleep quality of old adults. However, it is lacking of the evidence of the randomized controlled trial (RCT) of ear acupressure on insomnia.

Insomnia is related to homeostatic dysregulation of autonomic nervous system (ANS). Ear acupuncture and its related techniques are believed to act through the reticular formation and the ANS may thus result in an amelioration of illness.

In this study, a RCT is conducted to investigate the complementary effect of ear acupressure on chronic insomnia in old adults.Besides, the changes of ANS function (measured by heart rate variability) are recorded to evaluate the role of ANS in the treatment of insomnia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • clinical diagnosis of primary insomnia

排除标准

  • diabetic neuropathy
  • cardiac arrythmia
  • liver disease (ALT> 120 U/L)
  • renal disease (Cr> 2 mg/dl)
  • severe depression

结局指标

主要结局

polysomnography

时间窗: 4 weeks

次要结局

  • Pittsburgh sleep quality index, Heart rate variability, SF-36(4 weeks)

研究者

申办方类型
Other

研究点 (2)

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