Subjective Sleep and Fatigue During and After Acute Diverticulitis

Acute Diverticulitis Clinical Trial

Official title:

Subjective Sleep Quality and Fatigue During and After Acute Uncomplicated Diverticulitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840904
• Other study ID #: CHU-3
• Status: Completed
• Phase: N/A
• First received: April 13, 2013
• Last updated: February 24, 2014
• Start date: April 2013
• Est. completion date: November 2013

Study information

• Verified date: February 2014
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics CommitteeDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Diverticulitis
• Diverticulitis

Locations

Country	Name	City	State
Denmark	Department D, Herlev Hospital	Herlev	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Herlev Hospital	Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No