Acute DiverticulitisNCT01840904
Subjective Sleep and Fatigue During and After Acute Diverticulitis
An observational study of Acute Diverticulitis, run by Herlev Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Diverticulitis
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 16 x Acute uncomplicated diverticulitis (Hansen and stock stage 1) patients aged 18-75 years managed by antibiotic treatment at Herlev Hospital.
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Acute Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| acute uncomplicated diverticulitis | CT-verified acute uncomplicated diverticulitis managed by antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Sleep quantity registered by the sleep diary compared with actigraph measured sleep quantity at given time frame
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 1st and 2nd and 30th day following the admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Principal investigator, Ismail Gögenür, Herlev Hospital
- Investigators
- Ismail Gögenur, M.D., Principal investigator, University of Copenhagen, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840904
- Sponsor's protocol ID
- CHU-3
- Status last verified
- Feb 2014
- First submitted
- 13 Apr 2013
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective Sleep Quality and Fatigue During and After Acute Uncomplicated Diverticulitis
- ClinicalTrials.gov ID
- NCT01840904
- Acronym / sponsor ID
- CHU-3
- Conditions
- Acute Diverticulitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Apr 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute uncomplicated diverticulitis | – | –CT-verified acute uncomplicated diverticulitis managed by antibiotics |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 16 x Acute uncomplicated diverticulitis (Hansen and stock stage 1) patients aged 18-75 years managed by antibiotic treatment at Herlev Hospital.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
Pain measured on VAS
6 secondary outcomes
accuracy of sleep diary compared to actigraph in measuring sleep data
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
Time frame: 1st-2nd day and 30th day following the admission
correlation between fatigue and level of cytokines in patient's plasma
Time frame: 1st and 2nd and 30th day following the admission
correlation between pain and level of cytokines in patient's plasma
Time frame: 1st and 2nd and 30th day following the admission
correlation between sleepiness and level of cytokines in patient's plasma
Time frame: 1st and 2nd and 30th day following the admission
correlation between general well-being and level of cytokines in patient's plasma
Time frame: 1st and 2nd and 30th day following the admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismail Gögenur, M.D. principal investigator
University of Copenhagen, Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Diverticulitis, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2014.