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

Recruiting now · Not applicable

Conditions studied: Disease Bowel, Crohn Disease, Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT05835973

Run by

Hospices Civils de Lyon

People needed

216

Starts

2025-04-08

Expected to finish

2028-06-08

Last updated by the study team

2025-11-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• clinical remission: Harvey-Bradshaw score (HBI) < 5 for CD and a Mayo score < 3 for UC
• 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.

You may not qualify if…

• 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.
• Persons under psychiatric care.
• Persons admitted to a health or social institution for purposes other than research.
• Persons of full age who are subject to a legal protection measure (guardianship, curators).

Where it is running

• Lyon Sud hospital — Pierre-Bénite, France (enrolling)
• CHU Clermont-Ferrand, Hôpital d'Estaing — Clermont-Ferrand, France
• CHU Grenoble Hôpital Michallon-Site Nord — Grenoble, France
• CHU Saint Etienne — Saint-Etienne, France

Full record on ClinicalTrials.gov

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