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

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ClinicalTrials.gov Identifier: NCT00155441
Recruitment Status : Unknown
Verified May 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : January 9, 2007
Sponsor:
Collaborator:
Far Eastern Memorial Hospital
Information provided by:
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Sleep Disorders Kidney Diseases Behavioral: cognitive-behavioral therapy Phase 3

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 Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Cognitive-Behavioral Therapy on Sleep Disturbance in Peritoneal Dialysis Patients
Study Start Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders




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

Secondary Outcome Measures :
  1. The hematologic, biochemical markers, and peritoneal function in 1st and 3rd months


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00155441


Contacts
Contact: Tun-Jun Tsai, Ph.D., M.D +886-23123456 ext 3953 paul@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taiwan, Taiwan, 100
Contact: Tun-Jun Tsai, Ph.D., M.D    +886-23123456 ext 3953    paul@ha.mc.ntu.edu.tw   
Principal Investigator: Tun-Jun Tsai, Ph.D., M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Tun-Jun Tsai, Ph.D., M.D. Division of Nephrology, Department of Internal Medicine, National Taiwan University

ClinicalTrials.gov Identifier: NCT00155441     History of Changes
Other Study ID Numbers: 9461700509
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 9, 2007
Last Verified: May 2005

Keywords provided by National Taiwan University Hospital:
sleep disorder
peritoneal dialysis
cognitive-behavioral therapy
sleep disorder:C23.888.592.796
peritoneal dialysis: F03.870.664

Additional relevant MeSH terms:
Kidney Diseases
Sleep Wake Disorders
Parasomnias
Dyssomnias
Urologic Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders