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

Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00155441
• Other study ID #: 9461700509
• Status: Unknown status
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: January 8, 2007
• Start date: June 2005

Study information

• Verified date: May 2005
• Source: National Taiwan University Hospital
• Contact: Tun-Jun Tsai, Ph.D., M.D
• Phone: +886-23123456
• Email: paul[@]ha.mc.ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Kidney Diseases
• Parasomnias
• Sleep Disorders
• Sleep Wake Disorders

Intervention

Behavioral:
• cognitive-behavioral therapy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taiwan

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Check Pittsburgh Sleep Quality Index and restless leg syndrome index: in 1st and 3rd months
Secondary	The hematologic, biochemical markers, and peritoneal function in 1st and 3rd months