Clinical Trial: Sleep and Cytokines During Acute Diverticulitis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: the Effects of Inflammatory Cytokines on Sleep During Acute Diverticulitis

Brief Summary: The purpose of this study is to investigate sleep disturbances during Acute uncomplicated diverticulitis by polysomnography. The investigators hypothesis is the inflammation causes REM(rapid eye movement)-sleep reduction and this is correlated with plasma cytokine levels.

Detailed Summary:

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

Sponsor: Herlev Hospital

Current Primary Outcome:

• 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Herlev Hospital

Dates:
Date Received: April 13, 2013
Date Started: April 2013
Date Completion:
Last Updated: February 24, 2014
Last Verified: February 2014