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Recruiting NCT05835973

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

Trial Parameters

Condition Disease Bowel
Sponsor Hospices Civils de Lyon
Study Type INTERVENTIONAL
Phase N/A
Enrollment 216
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-04-08
Completion 2028-04-08
Interventions
Sleep activityQuestionnaires

Brief 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 Criteria

Inclusion Criteria: * Patient over 18 and under 65 years of age. * Patient with Inflammatory Bowel Disease diagnosed for at least 3 months. * Patient in remission, for at least 3 months: 1. clinical remission: Harvey-Bradshaw score (HBI) \< 5 for CD and a Mayo score \< 3 for UC 2. and biological remission: absence of objective inflammation defined by CRP \< 5 mg/L and/or fecal calprotectin \< 250 µg/g. * Patient must sign informed consent form to participate to the study. * Patient affiliated to or benefiting from a social security plan. Exclusion Criteria: * Patient with complications (obstructive symptoms, fistulas or intra-abdominal abscesses in the previous three months). * Patient with extensive bowel resection (\> 40 cm of small bowel). * Patient with an ileostomy or colostomy. * Patient diagnosed with sleep disorders. * Patient without legal capacity to consent. * Pregnant, parturient or nursing women. * Persons deprived of liberty by judicial or administrative decision. * Perso

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