Validation of Actigraph Measured Sleep During Acute Diverticulitis

Completed

• Conditions: Acute Diverticulitis

• Registration Number: NCT01840878
• Lead Sponsor: Herlev Hospital

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-13
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-26
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Sleep data during acute uncomplicated diverticulitis (1-5th days following the admission) from baseline at remission (5th-30th days)	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)	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	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

Trial Locations

Locations (1)

Department D, Herlev Hospital; 🇩🇰 Herlev, Copenhagen, Denmark