Renal FailureNCT00172471
The Relationship Between Sleep Disorders and Cytokine Levels Among Hemodialysis and Peritoneal Dialysis Patients
An observational study of Renal Failure and Sleep Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Failure, Sleep Disorder, Hemodialysis
- How many people
- Not given
- Where
- 1 siteTaiwan
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ESRD Patients with hemodialysis or peritoneal dialysis
Who cannot join
- Malignancy, hospitalization, infection, inflammation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital
Taipei, 100
About this study
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.
- Conditions
- Renal Failure, Sleep Disorder, Hemodialysis, Peritoneal Dialysis
- Medical subject headings
- Renal Insufficiency, Sleep Wake Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jenq-Wen Huang, MD, Principal investigator, Department of Internal Medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172471
- Sponsor's protocol ID
- 9361700775
- Status last verified
- Dec 2004
- First submitted
- 12 Sep 2005
- Last updated
- 21 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Sleep Disorders and Cytokine Levels Among Hemodialysis and Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT00172471
- Acronym / sponsor ID
- 9361700775
- Conditions
- Renal Failure, Sleep Disorder, Hemodialysis, Peritoneal Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ESRD Patients with hemodialysis or peritoneal dialysis
Key exclusion criteria (1 listed)
- Malignancy, hospitalization, infection, inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenq-Wen Huang, MD principal investigator
Department of Internal Medicine, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure and Sleep Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2005.