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

Official Title: “Effects of Cognitive-Behavioral Therapy on Sleep Disturbance in Peritoneal Dialysis Patients”

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.

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.

Intervention(s) in this Clinical Trial

• Behavioral: cognitive-behavioral therapy

Primary Measures

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

Secondary Measures

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: National Taiwan University Hospital Other

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Tun-Jun Tsai, Ph.D., M.D +886-23123456 paul@ha.mc.ntu.edu.tw

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00155441

Study ID Number: 9461700509

ClinicalTrials.gov Identifier: NCT00155441

Health Authority: Taiwan: Department of Health