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CompletedNCT01840852Updated Feb 25, 2014

Sleep and Cytokines During Acute Diverticulitis

An observational study in Acute Diverticulitis, sponsored by Herlev Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-02-25.

Sponsored by Herlev Hospital · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
13
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Acute Diverticulitis

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03

In context

Diverticulitis

146 studies on the registry are indexed under Diverticulitis; 26 are open to participants now.

This study's enrollment of 13 is below the median of 300 across 71 observational studies indexed under Diverticulitis.

Browse Diverticulitis studies →

Lead sponsor

Herlev Hospital is the lead sponsor of 195 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

16 x Acute uncomplicated diverticulitis (Hansen and stock stage 1) patients aged 18-75 years managed by antibiotic treatment at Herlev Hospital.

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

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
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
13 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • acute uncomplicated diverticulitis

    CT-verified acute uncomplicated diverticulitis managed by antibiotics

06

What researchers measure

Primary outcomes

  1. change in Sleep architecture during acute uncomplicated diverticulitis from baseline at the remission (30th day)

    Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings)

    Time frame: 1st, 2nd and 30th nights following the admission

  2. change in cytokine levels in plasma during the acute uncomplicated diverticulitis from baseline levels at remission

    the Blood sample is taken prior to night sleep; Cytokines are measured by commercial ELISA-kits

    Time frame: 1st, 2nd and 30th nights following the admission

  3. change in CRP level in plasma during the acute uncomplicated diverticulitis from baseline levels at remission

    the Blood sample is taken prior to night sleep; CRP is measured by standardized conventional method

    Time frame: 1st, 2nd and 30th nights following the admission

  4. change in leucocyte level in plasma during the acute uncomplicated diverticulitis from baseline levels at remission

    the Blood sample is taken prior to night sleep; Leucocyte is measured by standardized conventional method

    Time frame: 1st, 2nd and 30th nights following the admission

07

Study locations

1 site
  • Department D, Herlev Hospital
    Herlev, Copenhagen 2730, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01840852
Lead sponsor
Herlev Hospital
Collaborators
Lundbeck Foundation
Responsible party
Ismail Gögenür (Senior resident and D.Sc., Herlev Hospital) — Principal investigator
First posted
Apr 26, 2013
Start date
Apr 2013
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Feb 25, 2014

Study contacts

Ismail Gögenur, M.D.
principal investigator · University of Copenhagen, Herlev Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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