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NCT Number: NCT01840852

Sleep and Cytokines During Acute Diverticulitis

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.

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Key information

Conditions

Acute Diverticulitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department D, Herlev Hospital

Herlev, Copenhagen, 2730, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CT-verified diverticulitis patients managed by antibiotic treatment at Herlev Hospital
  • Pain and fever occurred less than 72 hours prior to the admission
  • ASA (American Society of Anesthesiologists) score I to III

Exclusion criteria

  • Surgical intervention needed
  • Complicated diverticulitis
  • Complications in relation to diverticulitis
  • Pain and fever occurred more than 72 hours prior to the admission
  • In anticoagulant treatment and heart rate control treatment
  • Known Autoimmune disease
  • Known medically treated sleep-disorder (insomnia, restless legs etc.) and sleep apnea
  • Shift-work or jetlag
  • Daily use of opioid, psychopharmaca, opioids or anxiolytics (including Hypnotics)
  • Known psychiatry conditions in treatment with psychopharmaca
  • Daily alcohol intake of more than 5 units or drug abuse
  • Missing written consent
  • Diabetes Mellitus
  • Predicted bad compliance
  • Pregnant or breast-feeding
  • Urine or fecal incontinence
  • Severe kidney disease
  • Current cancer

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Collaborators

  • Lundbeck Foundation

Registry information

Official study title

the Effects of Inflammatory Cytokines on Sleep During Acute Diverticulitis

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 26, 2013
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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