Validation of Actigraph Measured Sleep During Acute Diverticulitis

Acute Diverticulitis Clinical Trial

Official title:

Accuracy of Actigraph Measured Sleep Compared to Polysomnography During Acute Uncomplicated Diverticulitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840878
• Other study ID #: CHU-2
• Status: Completed
• Phase: N/A
• First received: April 13, 2013
• Last updated: February 24, 2014
• Start date: April 2013
• Est. completion date: November 2013

Study information

• Verified date: February 2014
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics CommitteeDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Diverticulitis
• Diverticulitis

Locations

Country	Name	City	State
Denmark	Department D, Herlev Hospital	Herlev	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Herlev Hospital	Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Sleep data during acute uncomplicated diverticulitis (1-5th days following the admission) from baseline at remission (5th-30th days)	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.	1st-30th days following the admission	No
Primary	Changes in Circadian rhythm during acute uncomplicated diverticulitis (1-5th days following the admission) from baseline at remission (5th-30th days)	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	No
Primary	Accuracy of actigraphy measured sleep data in compare to Polysomnography both in inflammatory condition and in remission condition	Sleep data measured by Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings) are to validate with the PSG-measured data	1st, 2nd and 30th days following the admission	No