Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.
Not applicable · Testing Sleep activity and Questionnaires · 4 sites · Hospices Civils de Lyon
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Sleep activity and Questionnaires. Condition(s) listed: Disease Bowel, Crohn Disease and Ulcerative Colitis.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- 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:
Plus 4 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 216 participants are expected to take part.
- Start date: 2025-04-08.
- Main results expected around 2028-04-08 (estimate from the record).
- 4 study sites listed (1 marked recruiting) in France.
Main thing being measured
- rate of relapse (12 months after baseline)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Disease Bowel; Crohn Disease; Ulcerative Colitis |
| Lead sponsor | Hospices Civils de Lyon |
| Enrollment | 216 (estimated) |
| Start date | 2025-04-08 |
| Primary completion (est.) | 2028-04-08 |
| First posted | 2023-04-28 |
| Last updated | 2025-11-21 |
| Official title | Evaluation of Sleep Changes as Early Markers of Relapse in Patients With Inflammatory Bowel Diseases (IBD). |
| ClinicalTrials.gov ID | NCT05835973 |
Interventions
- Sleep activity (Other)
Actinography : 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). Ancillary study : DREEM 3 headband : a subgroup of patients will wear the headband during 2 nights every 3 months. - Questionnaires (Other)
The PSQI, EPWORTH, FACIT-F, ISI, and ICSD-3 questionnaires will be completed by patients every 3 months during their follow-up consultation according to the usual management. The questionnaire by Horne and Ostberg will be completed by the patients only during the inclusion visit.
Full eligibility criteria (from the record)
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).
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.