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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
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Ismail Gögenür, Herlev Hospital

Tracking Information
First Submitted Date April 13, 2013
First Posted Date April 26, 2013
Last Update Posted Date February 25, 2014
Study Start Date April 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2013)
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01840878 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of Actigraph Measured Sleep During Acute Diverticulitis
Official Title Accuracy of Actigraph Measured Sleep Compared to Polysomnography During Acute Uncomplicated Diverticulitis
Brief Summary The purpose of this study is to investigate the accuracy of actigraph measured sleep compared to the golden standard (polysomnography) during Acute uncomplicated diverticulitis. Our hypothesis is the actigraph is accurate for sleep-monitoring for this group of patients
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 Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Acute Diverticulitis
Intervention Not Provided
Study Groups/Cohorts Acute Diverticulitis
CT-verified acute uncomplicated diverticulitis managed by antibiotics
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 24, 2014)
13
Original Estimated Enrollment
 (submitted: April 23, 2013)
16
Actual Study Completion Date November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01840878
Other Study ID Numbers CHU-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ismail Gögenür, Herlev Hospital
Study Sponsor Herlev Hospital
Collaborators Lundbeck Foundation
Investigators
Principal Investigator: Ismail Gögenur, M.D. University of Copenhagen, Herlev Hospital
PRS Account Herlev Hospital
Verification Date February 2014