Evaluating sleep changes in patients with inflammatory bowel diseases.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Lyon Sud hospital
  Pierre-Bénite, France Recruiting
• CHU Clermont-Ferrand, Hôpital d'Estaing
  Clermont-Ferrand, France Not yet recruiting
• CHU Grenoble Hôpital Michallon-Site Nord
  Grenoble, France Not yet 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Observational study comparing inflammatory markers in IBD and non-IBD participants

  This study is trying to see how inflammation levels in people with Crohn's Disease and Ulcerative Colitis compare to those without these conditions when they start new treatments.

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• Evaluating robotic surgery for inflammatory bowel disease

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• How nutrition and body composition relate to outcomes in people with IBD

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.