NCT05835973

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).

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Disease Bowel
• Crohn Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-08
• Primary completion: 2028-04-08
• Completion: 2028-06-08
• First posted: 2023-04-28
• Last updated: 2025-11-21

Locations

4 sites across 1 country: France