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.
Key facts
- Who runs it
- Hospices Civils de Lyon
- Where
- Clermont-Ferrand, Grenoble, Pierre-Bénite, and Saint-Etienne, FranceSee the 4 sites
- Trial code
- Registry title
- Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.
- Status
- Recruiting
- People taking part
- 216 people, planned
- Started
- 8 Apr 2025
- Expected to end
- 8 Jun 2028
- Type of study
- Interventional
- Treatments tested
- Sleep activity
- Questionnaires
- Record updated
- 21 November 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Crohn's disease or ulcerative colitis who are in remission. It follows their sleep for one year to see if sleep changes before a flare.
- Age
- Over 18 and under 65 years
- Sex
- All sexes
- Disease stage
- Inflammatory bowel disease diagnosed at least 3 months ago, in remission for at least 3 months. Clinical remission: Harvey-Bradshaw score (HBI) < 5 for Crohn's disease, Mayo score < 3 for ulcerative colitis. Biological remission: CRP < 5 mg/L and/or fecal calprotectin < 250 µg/g.
- Biomarker or test result
- No signs of inflammation: CRP < 5 mg/L and/or fecal calprotectin < 250 µg/g.
Main reasons for not taking part
- Complications in the previous 3 months (obstructive symptoms, fistulas or abscesses in the abdomen)
- Large bowel resection (> 40 cm (16 in) of small bowel)
- Ileostomy or colostomy
- Diagnosed sleep disorder
- Pregnant, giving birth or nursing
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in France
- CHU Clermont Ferrand - Hôpital d'EstaingClermont-Ferrand, FranceContact: Anthony BUISSONNot yet recruiting
- CHU Grenoble Hôpital Michallon-Site NordGrenoble, FranceContact: Nicolas MATHIEUNot yet recruiting
- Lyon Sud HospitalPierre-Bénite, FranceContact: Gilles BOSCHETTi, MD,PhDTaking people
- CHU Saint-EtienneSaint-Etienne, FranceContact: Xavier RoblinNot yet recruiting
About the trial
What the trial wants to find out
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
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.
The group in the trial
- Sleep activityTreatment being tested
Actigraphy : Patient will wear actinometers on the wrist for 1 year continuously. In the study, MotionWatch 8 actimeters will be used, a class 1 medical device with CE mark (EN ISO 13485:2016 standard). They will be provided by the company camntech. Ancillary Study: DREEM 3 headband : a subgroup of patients will wear the headband during 2 nights every 3 months.
Treatment: Sleep activity and Questionnaires
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of Sleep Changes as Early Markers of Relapse in Patients With Inflammatory Bowel Diseases (IBD).
- Plain-language title
- Tracking Sleep Changes as Early Warning Signs in Inflammatory Bowel DiseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05835973, who can take part
- Record updated
- 21 November 2025