Actively Recruiting
Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.
Led by Hospices Civils de Lyon · Updated on 2025-11-21
216
Participants Needed
4
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with clinical remission (Harvey-Bradshaw score < 5 for Crohn Disease and Mayo score < 3 for Ulcerative Colitis).
- Patient in biological remission with CRP < 5 mg/L and/or fecal calprotectin < 250 g/g.
- Patient must sign informed consent.
- Patient affiliated with or benefiting from a social security plan.
You will not qualify if you...
- Patient with complications such as 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 reasons other than research.
- Persons under legal protection measures such as guardianship or curatorship.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
CHU Clermont-Ferrand, Hôpital d'Estaing
Clermont-Ferrand, France, 63100
Not Yet Recruiting
2
CHU Grenoble Hôpital Michallon-Site Nord
Grenoble, France, 38700
Not Yet Recruiting
3
Lyon Sud hospital
Pierre-Bénite, France, 69310
Actively Recruiting
4
CHU Saint Etienne
Saint-Etienne, France, 42270
Not Yet Recruiting
Research Team
G
Gilles Boschetti, MD,PhD
CONTACT
M
Maelys Cheviakoff
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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