Skip to main content
OpenTrials
Completed

NCT Number: NCT01840878

Validation of Actigraph Measured Sleep During Acute Diverticulitis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Diverticulitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department D, Herlev Hospital

Herlev, Copenhagen, 2730, Denmark

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Collaborators

  • Lundbeck Foundation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 26, 2013
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.