Clinical trial NCT01840904: Subjective Sleep and Fatigue During and After Acute Diverticulitis
Official title: Subjective Sleep Quality and Fatigue During and After Acute Uncomplicated Diverticulitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Diverticulitis
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2013-04-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Sleep quality during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day)
timeFrame: 1st-10th day and 14th, 21st, 30th day following the admission
measure: Changes in Sleepiness during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day)
timeFrame: 1st-10th day and 14th, 21st, 30th day following the admission
measure: Changes in fatigue during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day)
timeFrame: 1st-10th day and 14th, 21st, 30th day following the admission
measure: Changes in general well-being during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day)
timeFrame: 1st-10th day and 14th, 21st, 30th day following the admission
measure: Changes in pain during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day)
timeFrame: 1st-10th day and 14th, 21st, 30th day following the admission
Secondary outcomes:
measure: accuracy of sleep diary compared to actigraph in measuring sleep data
timeFrame: 1st-10th day and 14th, 21st, 30th day following the admission
measure: accuracy of sleep diary compared to Polysomnography (PSG) in measuring sleep data
timeFrame: 1st-2nd day and 30th day following the admission
measure: correlation between fatigue and level of cytokines in patient's plasma
timeFrame: 1st and 2nd and 30th day following the admission
measure: correlation between pain and level of cytokines in patient's plasma
timeFrame: 1st and 2nd and 30th day following the admission
measure: correlation between sleepiness and level of cytokines in patient's plasma
timeFrame: 1st and 2nd and 30th day following the admission
measure: correlation between general well-being and level of cytokines in patient's plasma
timeFrame: 1st and 2nd and 30th day following the admission
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department D, Herlev Hospital
state: Copenhagen
Study officials:
affiliation: University of Copenhagen, Herlev Hospital
name: Ismail Gögenur, M.D.
role: PRINCIPAL_INVESTIGATOR
References: