Tracking Sleep Changes as Early Warning Signs in Inflammatory Bowel Disease
Studies whether sleep changes can signal a flare in Crohn disease or ulcerative colitis.
Plain-language title generated from the registry record
Registry title: Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.
Key facts
- Where
- Clermont-Ferrand, Grenoble, Pierre-Bénite, and Saint-Etienne, FranceSee the 4 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT05835973, who can take part
Where in France
- CHU Clermont Ferrand - Hôpital d'EstaingClermont-Ferrand, FranceNot yet recruiting
- CHU Grenoble Hôpital Michallon-Site NordGrenoble, FranceNot yet recruiting
- Lyon Sud HospitalPierre-Bénite, FranceTaking people
- CHU Saint-EtienneSaint-Etienne, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospices Civils de Lyon
- Trial code
- NCT05835973
- Record updated
- 21 November 2025
- Original description
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.Read full original descriptionShow less
Evaluation of Sleep Changes as Early Markers of Relapse in Patients With Inflammatory Bowel Diseases (IBD).
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.
Inclusion: 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.
Exclusion: 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 diagnosed with sleep disorders; Persons under psychiatric care; Persons of full age who are subject to a legal protection measure (guardianship, curators); Patient with an ileostomy or colostomy; Patient without legal capacity to consent; Pregnant, parturient or nursing women; Persons deprived of liberty by judicial or administrative decision; Persons admitted to a health or social institution for purposes other than research.