NCT05835973Recruiting
Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.
Evaluation of Sleep Changes as Early Markers of Relapse in Patients With Inflammatory Bowel Diseases (IBD).
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 216 (estimated)
- First submitted
- 19 Apr 2023
- Start date
- 8 Apr 2025
- Primary completion date
- 8 Apr 2028
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT05835973
What you commit to
- Study type: Interventional
- Planned participants: 216
- From 8 Apr 2025 to the primary completion date, 8 Apr 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Patient diagnosed with sleep disorders.
- Persons under psychiatric care.
Age
- Persons of full age who are subject to a legal protection measure (guardianship, curators).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Clermont Ferrand - Hôpital d'Estaing Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Not yet recruiting |
| CHU Grenoble Hôpital Michallon-Site Nord Coordinator of this site? Confirm its status | Grenoble | France | Not yet recruiting |
| Lyon Sud Hospital Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| CHU Saint-Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.