- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01840878
Validation of Actigraph Measured Sleep During Acute Diverticulitis
Accuracy of Actigraph Measured Sleep Compared to Polysomnography During Acute Uncomplicated Diverticulitis
Study Overview
Status
Conditions
Detailed Description
The actigraph has been proven to measured sleep data with an accuracy about 80% (compared with Polysomnography) in patients who have undergone surgery.
But this accuracy has not been validated in relation to none surgical inflammatory diseases. This study will investigate the accuracy of actigraph measured sleep in diverticulitis patients.
Following methods will be applied
Device: Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA
Other: Sleep-diary
Device: Polysomnograph - Embla Titanium (Natus Medical Incorporated, USA)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Copenhagen
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Herlev, Copenhagen, Denmark, 2730
- Department D, Herlev Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Acute Diverticulitis
CT-verified acute uncomplicated diverticulitis managed by antibiotics
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Sleep data during acute uncomplicated diverticulitis (1-5th days following the admission) from baseline at remission (5th-30th days)
Time Frame: 1st-30th days following the admission
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Sleep measured by Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings).
A wrist actigraph wil be worn from 1st day of the admission and taken off on the 31st day.
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1st-30th days following the admission
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Changes in Circadian rhythm during acute uncomplicated diverticulitis (1-5th days following the admission) from baseline at remission (5th-30th days)
Time Frame: 1st-30th days following the admission
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Circadian rhythm measured by Actigraphy.
A wrist actigraph wil be worn from 1st day of the admission and taken off on the 31st day.
|
1st-30th days following the admission
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Accuracy of actigraphy measured sleep data in compare to Polysomnography both in inflammatory condition and in remission condition
Time Frame: 1st, 2nd and 30th days following the admission
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Sleep data measured by Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings) are to validate with the PSG-measured data
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1st, 2nd and 30th days following the admission
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ismail Gögenur, M.D., University of Copenhagen, Herlev Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-2
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