Subjective Sleep and Fatigue During and After Acute Diverticulitis

Subjective Sleep Quality and Fatigue During and After Acute Uncomplicated Diverticulitis

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.

Study Overview

• Status: Completed
• Conditions: Acute Diverticulitis

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

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Herlev, Copenhagen, Denmark, 2730
      • Department D, Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
acute uncomplicated diverticulitis; CT-verified acute uncomplicated diverticulitis managed by antibiotics

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Collaborators: Lundbeck Foundation
• Investigators: Principal Investigator: Ismail Gögenur, M.D., University of Copenhagen, Herlev Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: April 13, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (Estimate): April 26, 2013

Study Record Updates

• Last Update Posted (Estimate): February 25, 2014
• Last Update Submitted That Met QC Criteria: February 24, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Diverticulitis
• Other Study ID Numbers: CHU-3