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. Our study try to eulucidate its therapeutic effect on the sleep disturbance in chronic peritoneal dialysis patients.

Condition	Intervention	Phase
sleep disorder:C23.888.592.796 peritoneal dialysis: F03.870.664	Behavior: cognitive-behavioral therapy	Phase III

Further Study Details: 

Primary Outcomes: Check Pittsburgh Sleep Quality Index and restless leg syndrome index:in 1st and 3rd months
Secondary Outcomes: The hematologic, bichemical markers and peritoneal function; in month 1st and 3rd months
Expected Total Enrollment:  30

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 hyponotics 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 try to eulucidate the therapeutic effect of cognitive-behavioral therapy on the sleep disturbance in chronic peritoneal dialysis patients.

We will perform cognitive-behavioral therapy to eligible periotneal dilaysis patients and evalute 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Undergoing PD for at least 3 months
• Older than 18 years old
• Have sleep disturbance subjectively

Exclusion Criteria:

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00155441

Tun-Jun Tsai, Ph.D. & M.D      +886-23123456  Ext. 3953    paul@ha.mc.ntu.edu.tw

Taiwan
      National Taiwan Universithy Hospital, Taiwan,  100,  Taiwan; Recruiting

Study chairs or principal investigators

Tun-Jun Tsai, Ph.D. & M.D.,  Principal Investigator,  Division of Nephrology, Department of Internal Medicine, National Taiwan University   

Study ID Numbers:  9461700509
Last Updated:  September 12, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00155441
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13