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NCT05835973 | NOT YET RECRUITING | Disease Bowel

Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.
Sponsor:

Civil Hospices of Lyon

Brief Summary:

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.

Condition or disease

Disease Bowel

Crohn Disease

Ulcerative Colitis

Intervention/treatment

Sleep activity

Questionnaires

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 216 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Evaluation of Sleep Changes As Early Markers of Relapse in Patients with Inflammatory Bowel Diseases (IBD).
Actual Study Start Date : 2025-01-01
Estimated Primary Completion Date : 2028-01-01
Estimated Study Completion Date : 2028-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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).
Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.

Location Details

NCT05835973

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

France,

Clermont-Ferrand University Hospital, Estaing Hospital

Clermont-Ferrand, France, 63100

Not yet recruiting

France,

CHU Grenoble Michallon Hospital-North Site

Grenoble, France, 38700

Not yet recruiting

France,

Lyon Sud hospital

Pierre-Bénite, France, 69310

Not yet recruiting

France,

Chu Saint ATN

Saint Etienne, France, 42270