Subjective Sleep and Fatigue During and After Acute Diverticulitis

NCT01840904 | Completed DMC

• 1 other identifier: CHU-3
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Diverticulitis

Outcome Measures

Primary Outcomes (5)

• Changes in Sleep quality during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day)

  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

  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)

  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

  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 Outcomes (6)

• accuracy of sleep diary compared to actigraph in measuring sleep data

  1st-10th day and 14th, 21st, 30th day following the admission

• accuracy of sleep diary compared to Polysomnography (PSG) in measuring sleep data

  1st-2nd day and 30th day following the admission

• correlation between fatigue and level of cytokines in patient's plasma

  1st and 2nd and 30th day following the admission

• correlation between pain and level of cytokines in patient's plasma

  1st and 2nd and 30th day following the admission

• correlation between sleepiness and level of cytokines in patient's plasma

  1st and 2nd and 30th day following the admission

Study Arms (1)

acute uncomplicated diverticulitis

CT-verified acute uncomplicated diverticulitis managed by antibiotics

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev Hospital: lead
• Lundbeck Foundation: collaborator

Study Sites (1)

Department D, Herlev Hospital

Herlev, Copenhagen, 2730, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

Study Officials

• Ismail Gögenur, M.D.

  University of Copenhagen, Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior resident and D.Sc.

Study Record Dates

• First Submitted: April 13, 2013
• First Posted: April 26, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

DK (1)