Validation of Actigraph Measured Sleep During Acute Diverticulitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01840878|
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : February 25, 2014
|Condition or disease|
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
Device: Polysomnograph - Embla Titanium (Natus Medical Incorporated, USA)
|Study Type :||Observational|
|Actual Enrollment :||13 participants|
|Official Title:||Accuracy of Actigraph Measured Sleep Compared to Polysomnography During Acute Uncomplicated Diverticulitis|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
CT-verified acute uncomplicated diverticulitis managed by antibiotics
- 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 ]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.
- 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 ]Circadian rhythm measured by Actigraphy. A wrist actigraph wil be worn from 1st day of the admission and taken off on the 31st day.
- 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 ]Sleep data measured by Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings) are to validate with the PSG-measured data
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840878
|Department D, Herlev Hospital|
|Herlev, Copenhagen, Denmark, 2730|
|Principal Investigator:||Ismail Gögenur, M.D.||University of Copenhagen, Herlev Hospital|