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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00155441
Enrollment
30
Registered
2005-09-12
Start date
2005-06-30
Completion date
Unknown
Last updated
2007-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Diseases, Sleep Disorders

Keywords

sleep disorder, peritoneal dialysis, cognitive-behavioral therapy, sleep disorder:C23.888.592.796, peritoneal dialysis: F03.870.664

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.

Interventions

BEHAVIORALcognitive-behavioral therapy

Sponsors

Far Eastern Memorial Hospital
CollaboratorOTHER
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

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

Secondary

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

Countries

Taiwan

Contacts

Primary ContactTun-Jun Tsai, Ph.D., M.D
paul@ha.mc.ntu.edu.tw+886-23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026