Evaluating sleep changes in patients with inflammatory bowel diseases.
Evaluation of Sleep Changes as Early Markers of Relapse in Patients With Inflammatory Bowel Diseases (IBD).
This study is trying to see if better sleep can help people with inflammatory bowel diseases, like Crohn's and ulcerative colitis, avoid flare-ups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 4 sites (Clermont-Ferrand and 3 other locations) |
| Trial ID | NCT05835973 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the relationship between sleep quality and the risk of flare-ups in patients with inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis. Patients who have been in remission for at least three months will undergo evaluations of their IBD symptoms and sleep patterns over the course of one year. The study will utilize various methods including actigraphy, questionnaires, and clinical assessments to monitor changes in sleep efficacy and its potential predictive value for IBD flare-ups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of inflammatory bowel disease in remission for at least three months.
Not a fit: Patients with active complications, extensive bowel resections, or pre-existing sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk of flare-ups based on sleep patterns, leading to timely interventions.
How similar studies have performed: While the relationship between sleep and IBD is being explored, this specific approach to predicting flare-ups through sleep assessment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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. * 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 this trial is running
Clermont-Ferrand and 3 other locations
- CHU Clermont-Ferrand, Hôpital d'Estaing — Clermont-Ferrand, France (Not_yet_recruiting)
- CHU Grenoble Hôpital Michallon-Site Nord — Grenoble, France (Not_yet_recruiting)
- Lyon Sud hospital — Pierre-Bénite, France (Recruiting)
- CHU Saint Etienne — Saint-Etienne, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Gilles Boschetti, MD,PhD
- Email: gilles.boschetti@chu-lyon.fr
- Phone: +33 4 78 86 13 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.