CompletedNot Applicable

Validation of Actigraph Measured Sleep During Acute Diverticulitis

Denmark13 participantsStarted 2013-04

Plain-language 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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1st-30th days following the admission

Changes in Circadian rhythm during acute uncomplicated diverticulitis (1-5th days following the admission) from baseline at remission (5th-30th days)

Timeframe: 1st-30th days following the admission

Accuracy of actigraphy measured sleep data in compare to Polysomnography both in inflammatory condition and in remission condition

Timeframe: 1st, 2nd and 30th days following the admission

Trial details

NCT IDNCT01840878

SponsorHerlev Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Acute Diverticulitis trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 1st-30th days following the admission

Changes in Circadian rhythm during acute uncomplicated diverticulitis (1-5th days following the admission) from baseline at remission (5th-30th days)

Timeframe: 1st-30th days following the admission

Accuracy of actigraphy measured sleep data in compare to Polysomnography both in inflammatory condition and in remission condition

Timeframe: 1st, 2nd and 30th days following the admission