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RECRUITING
NCT05835973
NA

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

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

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

OTHER

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.

OTHER

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