Effects of Cognitive-Behavioral Therapy on Sleep Disturbance in Peritoneal Dialysis Patients
Primary Purpose
Sleep Disorders, Kidney Diseases
Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
cognitive-behavioral therapy
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disorders focused on measuring sleep disorder, peritoneal dialysis, cognitive-behavioral therapy, sleep disorder:C23.888.592.796, peritoneal dialysis: F03.870.664
Eligibility 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
Sites / Locations
- National Taiwan University HospitalRecruiting
Outcomes
Primary Outcome Measures
Check Pittsburgh Sleep Quality Index and restless leg syndrome index: in 1st and 3rd months
Secondary Outcome Measures
The hematologic, biochemical markers, and peritoneal function in 1st and 3rd months
Full Information
NCT ID
NCT00155441
First Posted
September 8, 2005
Last Updated
January 8, 2007
Sponsor
National Taiwan University Hospital
Collaborators
Far Eastern Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00155441
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2005
Overall Recruitment Status
Unknown status
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Far Eastern Memorial Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, Kidney Diseases
Keywords
sleep disorder, peritoneal dialysis, cognitive-behavioral therapy, sleep disorder:C23.888.592.796, peritoneal dialysis: F03.870.664
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
cognitive-behavioral therapy
Primary Outcome Measure Information:
Title
Check Pittsburgh Sleep Quality Index and restless leg syndrome index: in 1st and 3rd months
Secondary Outcome Measure Information:
Title
The hematologic, biochemical markers, and peritoneal function in 1st and 3rd months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tun-Jun Tsai, Ph.D., M.D
Phone
+886-23123456
Ext
3953
Email
paul@ha.mc.ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tun-Jun Tsai, Ph.D., M.D.
Organizational Affiliation
Division of Nephrology, Department of Internal Medicine, National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taiwan
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tun-Jun Tsai, Ph.D., M.D
Phone
+886-23123456
Ext
3953
Email
paul@ha.mc.ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Tun-Jun Tsai, Ph.D., M.D.
12. IPD Sharing Statement
Learn more about this trial
Effects of Cognitive-Behavioral Therapy on Sleep Disturbance in Peritoneal Dialysis Patients
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