Evaluation of Sleep Changes as Early Markers of Relapse in Patients With Inflammatory Bowel Diseases (IBD).

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Clermont-Ferrand, Hôpital d'Estaing
NOT_YET_RECRUITING
Clermont-ferrand
CHU Grenoble Hôpital Michallon-Site Nord
NOT_YET_RECRUITING
Grenoble
Lyon Sud hospital
RECRUITING
Pierre-bénite
CHU Saint Etienne
NOT_YET_RECRUITING
Saint-etienne
Contact Information
Primary
Gilles Boschetti, MD,PhD
gilles.boschetti@chu-lyon.fr
+33 4 78 86 13 02
Backup
Maelys Cheviakoff
maelys.cheviakoff01@chu-lyon.fr
+33 4 78 86 37 66
Time Frame
Start Date: 2025-04-08
Estimated Completion Date: 2028-05-01
Participants
Target number of participants: 216
Treatments
Experimental: Sleep activity
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.
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov