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Sleep and Cytokines During Acute Diverticulitis

the Effects of Inflammatory Cytokines on Sleep During Acute Diverticulitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01840852
Enrollment
13
Registered
2013-04-26
Start date
2013-04-30
Completion date
2013-11-30
Last updated
2014-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 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

Interventions

None listed

Sponsors

Lundbeck Foundation
CollaboratorOTHER
Herlev Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in Sleep architecture during acute uncomplicated diverticulitis from baseline at the remission (30th day)1st, 2nd and 30th nights following the admissionSleep 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 remission1st, 2nd and 30th nights following the admissionthe 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 remission1st, 2nd and 30th nights following the admissionthe 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 remission1st, 2nd and 30th nights following the admissionthe Blood sample is taken prior to night sleep; Leucocyte is measured by standardized conventional method

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026