Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT01840904
Status:
COMPLETED
Last Update Posted:
2014-02-25
First Post:
2013-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Subjective Sleep and Fatigue During and After Acute Diverticulitis
Sponsor:
Herlev Hospital
Organization:
Study Overview
Official Title:
Subjective Sleep Quality and Fatigue During and After Acute Uncomplicated Diverticulitis
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: