Sleep and Cytokines During Acute Diverticulitis

Completed

• Conditions: Acute Diverticulitis

• Registration Number: NCT01840852
• Lead Sponsor: Herlev Hospital

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 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

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-13
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-26
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in cytokine levels in plasma during the acute uncomplicated diverticulitis from baseline levels at remission	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	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 Sleep architecture during acute uncomplicated diverticulitis from baseline at the remission (30th day)	1st, 2nd and 30th nights following the admission	Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings)
change in leucocyte level in plasma during the acute uncomplicated diverticulitis from baseline levels at remission	1st, 2nd and 30th nights following the admission	the Blood sample is taken prior to night sleep; Leucocyte is measured by standardized conventional method

Trial Locations

Locations (1)

Department D, Herlev Hospital; 🇩🇰 Herlev, Copenhagen, Denmark