Clinical trial NCT05835973: Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.
Official title: Evaluation of Sleep Changes as Early Markers of Relapse in Patients With Inflammatory Bowel Diseases (IBD).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disease Bowel
Crohn Disease
Ulcerative Colitis
Keywords: Inflammatory Bowel Diseases
Crohn's disease
ulcerative colitis
sleep deprivation
relapse
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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).

Primary outcomes:
measure: rate of relapse
timeFrame: 12 months after baseline
Secondary outcomes:
measure: Sleep efficiency calculated by actimetry and expressed in percentage.
timeFrame: 12 months after baseline
measure: Intra-sleep wakefulness duration (min), sleep latency (min) and sleep duration (min)
timeFrame: 12 months after baseline
measure: total sleep time
timeFrame: 12 months after baseline
measure: sleep onset latency
timeFrame: 12 months after baseline
measure: intra-sleep wake duration
timeFrame: 12 months after baseline
measure: polysomnographic sleep efficiency
timeFrame: 12 months after baseline
measure: quantity of different sleep stages
timeFrame: 12 months after baseline
measure: index of micro-arousals
timeFrame: 12 months after baseline
measure: spindle density
timeFrame: 12 months after baseline
measure: delta spectral power in slow wave sleep
timeFrame: 12 months after baseline
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand, Hôpital d'Estaing
city: Grenoble
country: France
facility: CHU Grenoble Hôpital Michallon-Site Nord
city: Pierre-Bénite
country: France
facility: Lyon Sud hospital
city: Saint Etienne
country: France
facility: CHU Saint Etienne
Study officials:
References: