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Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.
Sponsor: Hospices Civils de Lyon
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.
Official title: Evaluation of Sleep Changes as Early Markers of Relapse in Patients With Inflammatory Bowel Diseases (IBD).
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
216
Start Date
2025-04-08
Completion Date
2028-06-08
Last Updated
2025-11-21
Healthy Volunteers
No
Interventions
Sleep 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.
Questionnaires
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.
Locations (4)
CHU Clermont-Ferrand, Hôpital d'Estaing
Clermont-Ferrand, France
CHU Grenoble Hôpital Michallon-Site Nord
Grenoble, France
Lyon Sud hospital
Pierre-Bénite, France
CHU Saint Etienne
Saint-Etienne, France