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

Civil Hospices of Lyon

Status: Enrolling

Conditions: Disease Bowel; Ulcerative Colitis; Crohn Disease

Treatments: Other: Sleep activity; Other: Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT05835973

69HCL22_0907

Details and patient eligibility

About

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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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216 participants in 1 patient group

Sleep activity

Experimental group

Description:

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.

Treatment:

Other: Questionnaires

Other: Sleep activity