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Clinical Trials/NCT00155441
NCT00155441UnknownPhase 3

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

National Taiwan University Hospital1 site in 1 country30 target enrollmentStarted: June 1, 2005Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Enrollment
30
Locations
1
Primary Endpoint
Check Pittsburgh Sleep Quality Index and restless leg syndrome index: in 1st and 3rd months

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Investigators

Sponsor Class
Other

Study Sites (1)

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