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Official title Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.
ClinicalTrials.gov ID: NCT05835973
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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:
- 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
- Grenoble, France
- Pierre-Bénite, France
- Saint-Etienne, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France; Grenoble, France; Pierre-Bénite, France; Saint-Etienne, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.