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

NCT ID: NCT05835973

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-08
• Study Completion Date: 2028-06-08

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.

Conditions

Disease Bowel; Crohn Disease; Ulcerative Colitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sleep activity

Intervention Type: 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

Intervention Type: 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.

Interventions

Sleep activity

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.

Intervention Type: OTHER

Questionnaires

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.

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Clermont-Ferrand, Hôpital d'Estaing

Clermont-Ferrand, , France

Site Status: NOT_YET_RECRUITING

CHU Grenoble Hôpital Michallon-Site Nord

Grenoble, , France

Site Status: NOT_YET_RECRUITING

Lyon Sud hospital

Pierre-Bénite, , France

Site Status: RECRUITING

CHU Saint Etienne

Saint-Etienne, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Gilles Boschetti, MD,PhD

Role: CONTACT

gilles.boschetti@chu-lyon.fr

+33 4 78 86 13 02

Maelys Cheviakoff

Role: CONTACT

maelys.cheviakoff01@chu-lyon.fr

+33 4 78 86 37 66

Facility Contacts

Anthony BUISSON

Role: primary

Nicolas MATHIEU

Role: primary

Gilles BOSCHETTi, MD,PhD

Role: primary

Xavier Roblin

Role: primary

Other Identifiers

69HCL22_0907

Identifier Type: -

Identifier Source: org_study_id