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Cognitive-Behavioral Therapy for Sleep Disturbance in Patients Undergoing Hemodialysis and Its Impacts on Their Inflammatory Cytokines, Oxidative Stress and Autonomic Dysfunction

18 Years
80 Years
Open (Enrolling)
Insomnia, Depression, Inflammation

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Trial Information

Cognitive-Behavioral Therapy for Sleep Disturbance in Patients Undergoing Hemodialysis and Its Impacts on Their Inflammatory Cytokines, Oxidative Stress and Autonomic Dysfunction

Sleep disturbance is common in patients with renal disease. According to previous studies,
it occurs in more than 50% of chronic kidney disease (CKD) patients and those undergoing
dialysis. 1, 2 Insomnia, restless legs syndrome (RLS), daytime sleepiness, and sleep apnea
syndrome are common complaints; such sleep disturbances significantly affect the quality of
life, overall morbidity, hospitalization, and mortality. 3-5 The main remedy for sleep
disturbances, hypnotics, have notable side effects such as daytime sleepiness, psychological
dependence, and drug-to-drug interactions, which make these drugs less than an optimal
therapy. 6 Cognitive-behavioral therapy (CBT), the most widely used psychological
intervention for insomnia, combines cognitive strategies such as stimulus control and
relaxation training and has been proven to be effective for chronic insomnia in the elderly,
cancer patients, and chronic pain sufferers7, 8. In most published articles CBT has been
reported be superior to pharmacological and other behavioral therapies.9 In our previous
investigation10, we found that the CBT was effective in PD patients with sleep disturbance
presented with declined of Pittsburgh Sleep Quality Index (PSQI) and Fatigue Severity Scale
(FSS); furthermore, the inflammatory cytokines, such as IL-1β, IL-18, TNF-α also declined
after CBT in those insomnias PD patients. In previous studies, changes in cytokine release
correlated with insomnia in patients undergoing hemodialysis11 or with breast cancer.12
Nevertheless, the effectiveness of CBT of sleep disturbance in insomnias HD patients is
still not known.

In this study, we investigated the effectiveness of CBT for treatment of HD patients with
insomnia by assessing changes in sleep quality subjectively through self-report
questionnaires. The purpose of this study was to identify new therapeutic options for sleep
disorders beyond hypnotics in HD patients. Because the association of sleep disturbance,
oxidative stress and autonomic dysfunction in general population and patient with sleep
apnea were demonstrated in previous investigations, we also investigate the possible impacts
of CBT on the oxidative stress, autonomic dysfunction in these patients.

This study is designed to:

1. To evaluate the effectiveness of CBT for sleep disturbance in maintenance HD patients.

2. To evaluate the possible impacts of CBT on inflammatory cytokines, oxidative stress and
autonomic dysfunction in insomnias HD patients. .

3. To compare the systemic inflammation, oxidative stress and autonomic dysfunction in HD
patients with and without sleep disturbance.

Study designs and methods Eighty ESRD patients undergoing maintenance hemodialysis (HD) for
more than 6 months with subjective complaint of sleep disturbance and screening PSQI ≥ 5
will be recruited for the investigation. Besides, 40 ESRD patients undergoing HD for more
than 6 months without sleep disturbance will also be recruited as the population-base
control group. Insomnias HD patients (N=80) will be randomized into interventional group
(CBT group) and control group in 1:1 ratio in the following 6-week trial.

All participants (N=120) will receive questionnaires including 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) and check-ups of baroreflex sensitivity (BRS) for autonomic dysfunction
before the trial. Also, all of them will get fasting blood sampling at the initiation of
trial in the morning before mid-week HD section for analysis of inflammatory cytokines
(serum IL-1β, IL-18, and TNF-α levels) and oxidative stress (TBARS, Total antioxidant status
and serum 8-OHdG). Participants with sleep disturbance will be randomized into CBT group and
control group in 1:1 ratio and all of them receive sleep hygiene education before the trial.
Participants who randomized into the CBT group will receive 6 1-hour weekly treatment
sessions of CBT during the 6-week period. Participants who received hypnotics chronically
before being recruited were maintained at the same dose of hypnotics during the therapy.
After the 6-week trail, all participants will receive PSQI, FSS, BDI, IIEF, IFSF and BRS
again and 2nd blood sampling for analysis of inflammatory cytokine and oxidative stress
again. All the questionnaires, BRS and analyses of inflammatory cytokine and oxidative
stress will be performed again 3 months after the trial for the long-term follow-up
analysis. The details of investigation are demonstrated in Figure 1.

Inclusion Criteria:

- under maintenance hemodialysis for more than 6 months

- subjective sleep complaints and screening PSQI ≥ 5

Exclusion Criteria:

- active medical condition (hospitalization/surgery)

- active malignancy

- active infection

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

improvement of sleep disturbance/depression/anxiety

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Hung-Yuan Chen, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Far Eastern Memorial Hospital


Taiwan: Institutional Review Board

Study ID:




Start Date:

August 2009

Completion Date:

September 2010

Related Keywords:

  • Insomnia
  • Depression
  • Inflammation
  • sleep disturbance
  • cognitive behavioral therapy
  • inflammation
  • oxidative stress
  • hemodialysis
  • Depression
  • Depressive Disorder
  • Inflammation
  • Sleep Disorders
  • Dyssomnias
  • Parasomnias