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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00172471
Other study ID # 9361700775
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated December 20, 2005

Study information

Verified date December 2004
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

Sleep disorders are common in patients with end-stage renal disease on both hemodialysis and peritoneal dialysis and are associated with significant medical, psychological and social disturbances. Numerous factors have been suggested as contributing to or associated with the high prevalence of sleep disturbance in this population.

Increasing evidence suggests that cytokines are involved in the regulation of sleep and wakefulness and that the communication between the sleep and the immune system is bi-directional. Blood-dialyzer or peritoneum-dialysate interaction during dialysis therapy has the potential to activate mononuclear cells leading to production of inflammatory cytokines. These cytokines are believed to play a significant role in dialysis-associated morbidity and mortality. Nevertheless, a cytokine overproduction may alter sleep pattern in chronic dialyzed patients, thus explaining the presence of sleep disorders in these patients. In the other way, sleep loss may have effects on immune process and secretion of cytokines in chronic dialyzed patients. The purpose of this study was to examine the relationship between quality of sleep and serum cytokine levels in hemodialysis and peritoneal dialysis patients.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- ESRD Patients with hemodialysis or peritoneal dialysis

Exclusion Criteria:

- Malignancy, hospitalization, infection, inflammation

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional


Locations

Country Name City State
Taiwan Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

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