Subjective Sleep and Fatigue During and After Acute Diverticulitis

Study Overview
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Brief Summary
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The purpose of this study is to investigate subjective sleep quality and fatigue during and after Acute uncomplicated diverticulitis assessed by questionnaires and a sleep-diary. The investigators hypothesis is that subjective sleep and fatigue are correlated with the inflammatory activities.

Detailed Description
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An increasing number of experimental studies have showed that inflammation can induce disturbances in sleep architecture, mediated by cytokines. some studies showed that cytokines also induce daytime fatigue. In this study the investigators aim to describe the patient experiences of sleep and fatigue during the acute inflammation and the recovery, and the investigators seek to exam the correlation of fatigue with Polysomnography-measured night sleep and cytokine levels in plasma. Following methods will be applied Other: Karolinska Sleepiness Scale Other: Physical Fatigue Scale Other: Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain Other: Sleep-diary Device: Polysomnograph - Embla Titanium (Natus Medical Incorporated, USA) Procedure: Plasma cytokines (IL-2, IL-6 and TNF-alfa(tumor necrosis factor)) Procedure: Plasma CRP(C reactive protein) and leukocytes Device: Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA

Official Title
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Subjective Sleep Quality and Fatigue During and After Acute Uncomplicated Diverticulitis

Conditions
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Acute Diverticulitis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| acute uncomplicated diverticulitis<br>CT-verified acute uncomplicated diverticulitis managed by antibiotics | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Sleep quality during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day) | subjective sleep quality measured by a Visual Analog Scale (VAS) at given time frame sleep-diary recording sleep quantity of day and night sleep at given time frame | 1st-10th day and 14th, 21st, 30th day following the admission | 
| Changes in Sleepiness during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day) | Sleepiness measured by Karolinska Sleepiness Scale at given time frame | 1st-10th day and 14th, 21st, 30th day following the admission | 
| Changes in fatigue during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day) | General fatigue measured on Visual Analog Scale at given time frame Physical fatigue measured on a 10 points scale at given time frame | 1st-10th day and 14th, 21st, 30th day following the admission | 
| Changes in general well-being during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day) | general well being measured on VAS | 1st-10th day and 14th, 21st, 30th day following the admission | 
| Changes in pain during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day) | Pain measured on VAS | 1st-10th day and 14th, 21st, 30th day following the admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of sleep diary compared to actigraph in measuring sleep data | Sleep quantity registered by the sleep diary compared with actigraph measured sleep quantity at given time frame | 1st-10th day and 14th, 21st, 30th day following the admission | 
| accuracy of sleep diary compared to Polysomnography (PSG) in measuring sleep data | Sleep quantity registered by the sleep diary compared with PSG measured sleep quantity at given time frame | 1st-2nd day and 30th day following the admission | 
| correlation between fatigue and level of cytokines in patient's plasma | Investigator seek to find correlations between levels of IL-2, IL-6, TNF-alpha, CRP, Leucocytes and subjective fatigue measured by VAS and a 10 points scale. | 1st and 2nd and 30th day following the admission | 
| correlation between pain and level of cytokines in patient's plasma | Investigator seek to find correlations between levels of IL-2, IL-6, TNF-alpha, CRP, Leucocytes and subjective pain measured by VAS. | 1st and 2nd and 30th day following the admission | 
| correlation between sleepiness and level of cytokines in patient's plasma | Investigator seek to find correlations between levels of IL-2, IL-6, TNF-alpha, CRP, Leucocytes and subjective sleepiness measured by Karolinsk Sleepiness Scale | 1st and 2nd and 30th day following the admission | 
| correlation between general well-being and level of cytokines in patient's plasma | Investigator seek to find correlations between levels of IL-2, IL-6, TNF-alpha, CRP, Leucocytes and general well-being measured by VAS | 1st and 2nd and 30th day following the admission |