Sleep and Cytokines During Acute Diverticulitis
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|ClinicalTrials.gov Identifier: NCT01840852|
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : February 25, 2014
|Condition or disease|
An increasing number of experimental studies have showed that inflammation can induce disturbances in sleep architecture, mediated by cytokines. Sleep is important both in health and disease processes and can affect recovery, morbidity and mortality.
Studies have been done on sleep disturbances after major and minor GI-surgery but never in relation to none surgical inflammatory diseases, namely acute diverticulitis.
This study will investigate sleep architecture by Polysomnography and inflammation by levels of pro inflammatory cytokines in plasma.
Following methods will be applied
Device: Polysomnograph - Embla Titanium (Natus Medical Incorporated, USA)
Procedure: Plasma cytokines (IL-2, IL-6 and TNF(tumor necrosis factor-alfa)
Procedure: Plasma CRP(C reactive protein) and leukocytes
|Study Type :||Observational|
|Actual Enrollment :||13 participants|
|Official Title:||the Effects of Inflammatory Cytokines on Sleep During Acute Diverticulitis|
|Study Start Date :||April 2013|
|Primary Completion Date :||November 2013|
|Study Completion Date :||November 2013|
acute uncomplicated diverticulitis
CT-verified acute uncomplicated diverticulitis managed by antibiotics
- change in Sleep architecture during acute uncomplicated diverticulitis from baseline at the remission (30th day) [ Time Frame: 1st, 2nd and 30th nights following the admission ]Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings)
- change in cytokine levels in plasma during the acute uncomplicated diverticulitis from baseline levels at remission [ Time Frame: 1st, 2nd and 30th nights following the admission ]the Blood sample is taken prior to night sleep; Cytokines are measured by commercial ELISA-kits
- change in CRP level in plasma during the acute uncomplicated diverticulitis from baseline levels at remission [ Time Frame: 1st, 2nd and 30th nights following the admission ]the Blood sample is taken prior to night sleep; CRP is measured by standardized conventional method
- change in leucocyte level in plasma during the acute uncomplicated diverticulitis from baseline levels at remission [ Time Frame: 1st, 2nd and 30th nights following the admission ]the Blood sample is taken prior to night sleep; Leucocyte is measured by standardized conventional method
Biospecimen Retention: Samples Without DNA
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): NCT01840852
|Department D, Herlev Hospital|
|Herlev, Copenhagen, Denmark, 2730|
|Principal Investigator:||Ismail Gögenur, M.D.||University of Copenhagen, Herlev Hospital|