Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Subjective Sleep and Fatigue During and After Acute Diverticulitis

This study has been completed.
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Ismail Gögenür, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01840904
First received: April 13, 2013
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition
Acute Diverticulitis

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Subjective Sleep Quality and Fatigue During and After Acute Uncomplicated Diverticulitis

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Changes in Sleep quality during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day) [ Time Frame: 1st-10th day and 14th, 21st, 30th day following the admission ] [ Designated as safety issue: No ]
    1. subjective sleep quality measured by a Visual Analog Scale (VAS) at given time frame
    2. sleep-diary recording sleep quantity of day and night sleep at given time frame

  • Changes in Sleepiness during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day) [ Time Frame: 1st-10th day and 14th, 21st, 30th day following the admission ] [ Designated as safety issue: No ]
    Sleepiness measured by Karolinska Sleepiness Scale at given time frame

  • Changes in fatigue during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day) [ Time Frame: 1st-10th day and 14th, 21st, 30th day following the admission ] [ Designated as safety issue: No ]
    1. General fatigue measured on Visual Analog Scale at given time frame
    2. Physical fatigue measured on a 10 points scale at given time frame

  • Changes in general well-being during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day) [ Time Frame: 1st-10th day and 14th, 21st, 30th day following the admission ] [ Designated as safety issue: No ]
    general well being measured on VAS

  • Changes in pain during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day) [ Time Frame: 1st-10th day and 14th, 21st, 30th day following the admission ] [ Designated as safety issue: No ]
    Pain measured on VAS


Secondary Outcome Measures:
  • accuracy of sleep diary compared to actigraph in measuring sleep data [ Time Frame: 1st-10th day and 14th, 21st, 30th day following the admission ] [ Designated as safety issue: No ]
    Sleep quantity registered by the sleep diary compared with actigraph measured sleep quantity at given time frame

  • accuracy of sleep diary compared to Polysomnography (PSG) in measuring sleep data [ Time Frame: 1st-2nd day and 30th day following the admission ] [ Designated as safety issue: No ]
    Sleep quantity registered by the sleep diary compared with PSG measured sleep quantity at given time frame

  • correlation between fatigue and level of cytokines in patient's plasma [ Time Frame: 1st and 2nd and 30th day following the admission ] [ Designated as safety issue: No ]
    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.

  • correlation between pain and level of cytokines in patient's plasma [ Time Frame: 1st and 2nd and 30th day following the admission ] [ Designated as safety issue: No ]
    Investigator seek to find correlations between levels of IL-2, IL-6, TNF-alpha, CRP, Leucocytes and subjective pain measured by VAS.

  • correlation between sleepiness and level of cytokines in patient's plasma [ Time Frame: 1st and 2nd and 30th day following the admission ] [ Designated as safety issue: No ]
    Investigator seek to find correlations between levels of IL-2, IL-6, TNF-alpha, CRP, Leucocytes and subjective sleepiness measured by Karolinsk Sleepiness Scale

  • correlation between general well-being and level of cytokines in patient's plasma [ Time Frame: 1st and 2nd and 30th day following the admission ] [ Designated as safety issue: No ]
    Investigator seek to find correlations between levels of IL-2, IL-6, TNF-alpha, CRP, Leucocytes and general well-being measured by VAS


Biospecimen Retention:   Samples Without DNA

plasma


Enrollment: 13
Study Start Date: April 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
acute uncomplicated diverticulitis
CT-verified acute uncomplicated diverticulitis managed by antibiotics

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01840904

Locations
Denmark
Department D, Herlev Hospital
Herlev, Copenhagen, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Lundbeck Foundation
Investigators
Principal Investigator: Ismail Gögenur, M.D. University of Copenhagen, Herlev Hospital
  More Information

No publications provided

Responsible Party: Ismail Gögenür, Senior resident and D.Sc., Herlev Hospital
ClinicalTrials.gov Identifier: NCT01840904     History of Changes
Other Study ID Numbers: CHU-3
Study First Received: April 13, 2013
Last Updated: February 24, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Diverticulitis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Infection
Intraabdominal Infections

ClinicalTrials.gov processed this record on November 27, 2014