Cognitive-Behavioral Therapy for Sleep Disturbance in Patients Undergoing Hemodialysis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01159197|
Recruitment Status : Unknown
Verified November 2008 by Far Eastern Memorial Hospital.
Recruitment status was: Recruiting
First Posted : July 9, 2010
Last Update Posted : August 6, 2010
More than 50% of dialysis patients experience sleep disturbances that significantly affect quality of life, overall morbidity, and mortality. There is no effective therapy except hypnotics, which have notable side effects. Cognitive-behavioral therapy (CBT) is effective for treating peritoneal dialysis (PD) patients, the elderly and cancer patients with chronic insomnia, but its effectiveness has never been reported in hemodialysis (HD) patients and its impacts on the inflammatory cytokines, oxidative stress and autonomic dysfunction in this population are unknown. The investigators investigated the effectiveness of CBT in HD patients by assessing changes in sleep quality, inflammatory cytokines, oxidative stress and autonomic dysfunction.
This study is designed to assess the effectiveness of CBT on sleep disturbance in insomnias HD patients. The investigators also evaluate the impacts of CBT on the inflammatory cytokines, oxidative stress and autonomic dysfunction in these insomnias HD patients.
The investigators expected to recruit 80 insomnias HD patients undergoing maintenance HD for more than 3 months for the investigation. Besides, 40 HD patients without sleep disturbance will be recruited for comparison. Patients with sleep disturbance (N=80) was randomized to either intervention (CBT) group (N=40) or control group (N=40). Participants in CBT group will receive 6-week CBT while in control group and patients without sleep disturbance only receive sleep hygiene education. The subjects were assessed at baseline and after the intervention with the Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), Beck depression index (BDI) and the International Index of Erectile Function (IIEF) for men and the Index of Female Sexual Function (IFSF) for women; and inflammatory cytokines (serum IL-1β, IL-18, and TNF-α levels), oxidative stress (TBARS, Total antioxidant status and serum 8-OHdG) and autonomic dysfunction (Baroreflex sensitivity, BRS) were measured.
The investigators expect that CBT can improve the sleep disturbance in HD patients and may change the inflammatory cytokines, oxidative stress and autonomic dysfunction after the intervention in insomnias HD patients.
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Depression Inflammation||Behavioral: cognitive behavioral therapy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cognitive-Behavioral Therapy for Sleep Disturbance in Patients Undergoing Hemodialysis and Its Impacts on Their Inflammatory Cytokines, Oxidative Stress and Autonomic Dysfunction|
|Study Start Date :||August 2009|
|Estimated Primary Completion Date :||September 2010|
|Estimated Study Completion Date :||September 2010|
|Experimental: cognitive behaviorial therapy||
Behavioral: cognitive behavioral therapy
Participants who randomized into the CBT group will receive 18 30-minute tri-weekly treatment sessions of CBT during the 6-week period
Other Name: cognitive behavioral therpy
- improvement of sleep disturbance/depression/anxiety [ Time Frame: 6 weeks ]
- Changes of inflammatory cytokines/oxidative stress [ Time Frame: 6 weeks ]
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): NCT01159197
|Contact: Hung-Yuan Chen, M.D||886-2-89667000 ext email@example.com|
|Far Eastern Memorial Hospital||Recruiting|
|Taipei, Taiwan, 220|
|Contact: Hung-Yuan Chen, M.D 886-2-89667000 ext 1163 firstname.lastname@example.org|
|Principal Investigator: Hung-Yuan Chen, M.D|
|Principal Investigator:||Hung-Yuan Chen, M.D||Far Eastern Memorial Hospital|