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临床试验/NCT00155441
NCT00155441Unknown3 期

Effects of Cognitive-Behavioral Therapy on Sleep Disturbance in Peritoneal Dialysis Patients

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2005年6月最近更新:
适应症

试验速览

阶段
3 期
入组人数
30
试验地点
2
主要终点
Check Pittsburgh Sleep Quality Index and restless leg syndrome index: in 1st and 3rd months

研究概览

简要总结

Sleep disturbance is prevalent in chronic dialysis patients and there is a negative correlation between the quality of life and overall survival and sleep disturbance in them. Cognitive-behavioral therapy is an effective behavioral therapy for insomnia clinically. In previous studies, cognitive-behavioral therapy can redress anxiety in chronic hemodialysis patients. This study tries to elucidate its therapeutic effect on the sleep disturbance in chronic peritoneal dialysis patients.

详细描述

Sleep disturbance is prevalent in chronic dialysis patients and there is a negative correlation between the quality of life and overall survival and sleep disturbance in them. So many factors interfering the sleep of these patients, however, there is no effective therapy for them except some drugs, such as hypnotics or anxiolytics. Cognitive-behavioral therapy is an effective behavioral therapy for insomnia clinically and it contains three therapeutic domains including stimulus control, sleep restriction therapy, and relaxation training. It has been proven to be beneficial in improving sleep pattern in chronic insomnia and cancer patients and alcoholism. In previous studies, cognitive-behavioral therapy can redress anxiety in chronic hemodialysis patients, however, there is no clinical evidence revealing its effectiveness upon sleep disorders in hemodialysis and peritoneal dialysis patients. Our study tries to elucidate the therapeutic effect of cognitive-behavioral therapy on the sleep disturbance in chronic peritoneal dialysis patients.

We will perform cognitive-behavioral therapy to eligible peritoneal dialysis patients and evaluate the sleep condition before and after the therapy. Moreover, clinical conditions, biochemical and hematological parameters, inflammatory mediators in blood will be measured at baseline, before and after therapy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Undergoing peritoneal dialysis (PD) for at least 3 months
  • Older than 18 years
  • Have sleep disturbance subjectively

排除标准

  • Unstable clinical conditions or evidence of malignancy
  • Pregnancy
  • Participation in another study that would interfere with the outcome of this study

结局指标

主要结局

Check Pittsburgh Sleep Quality Index and restless leg syndrome index: in 1st and 3rd months

次要结局

  • The hematologic, biochemical markers, and peritoneal function in 1st and 3rd months

研究者

申办方类型
Other

研究点 (2)

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