Validation of Actigraph Measured Sleep During Acute Diverticulitis

Herlev Hospital

Status: Completed

Conditions: Acute Diverticulitis

Study type: Observational

Funder types: Other

Identifiers

NCT01840878

CHU-2

Details and patient eligibility

About

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

Full 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)

Enrollment: 13 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

13 participants in 1 patient group

Acute Diverticulitis

Description:

CT-verified acute uncomplicated diverticulitis managed by antibiotics