RecruitingNot ApplicableNCT05835973

Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.

Evaluation of Sleep Changes as Early Markers of Relapse in Patients With Inflammatory Bowel Diseases (IBD).

Sponsor

Hospices Civils de Lyon

Enrollment

216 participants

Start Date

Apr 8, 2025

Study Type

INTERVENTIONAL

Conditions

Crohn Disease Ulcerative Colitis Disease Bowel

Summary

Inflammatory Bowel Diseases (IBD) go through two phases: flare and remission. Prediction of flares and identification of patients in remission but at high risk of flare are a major issue when taking care of IBD patients. Considering close interactions between sleep, immunity and intestinal inflammation, sleep disorders could be a predictor of flares. The purpose of this study is to demonstrate that sleep efficacy decreases before IBD flare. Patients in remission will be assessed for IBD symptoms (activity scores, biological factors) and sleep disorders (actigraphy, DREEM®, questionnaires) during one year.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether people with inflammatory bowel disease (IBD) — including Crohn's disease and ulcerative colitis — who are in remission (no active flare-up) experience changes in their sleep quality and patterns. Researchers will compare sleep data between IBD patients and healthy individuals to better understand this connection. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with IBD (Crohn's disease or ulcerative colitis) for at least 3 months - Your disease has been in remission for at least the past 3 months (no active symptoms, confirmed by blood test and stool sample) **You may NOT be eligible if...** - You have had complications like bowel fistulas, abscesses, or obstructions in the past 3 months - You have had major bowel surgery removing a large section of intestine - You have a colostomy or ileostomy bag - You have already been diagnosed with a sleep disorder - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSleep activity

Actinography : Patient will wear actinometers on the wrist for 1 year continuously. In the study, MotionWatch 8 actimeters will be used, a class 1 medical device with CE mark (EN ISO 13485:2016 standard). Ancillary study : DREEM 3 headband : a subgroup of patients will wear the headband during 2 nights every 3 months.

OTHERQuestionnaires

The PSQI, EPWORTH, FACIT-F, ISI, and ICSD-3 questionnaires will be completed by patients every 3 months during their follow-up consultation according to the usual management. The questionnaire by Horne and Ostberg will be completed by the patients only during the inclusion visit.