Prevalence and Factors Associated With Sleep Disorders in Inflammatory Bowel Disease — SOMMICI  

Ulcerative Colitis Clinical Trial

Official title: Prevalence and Factors Associated With Sleep Disorders in Inflammatory Bowel Disease: a Cross-sectional Study at Reims University Hospital

Status Not yet recruiting

Clinical Trial Summary

Inflammatory bowel diseases (IBD) including Crohn's disease (CD) and ulcerative colitis (UC), are an inflammatory disease that can affect the entire digestive tract from the mouth to the anus for CD and the entire colon and rectum for UC. They mainly affect adolescents and young adults. These pathologies evolve in relapses interspersed with phases of remission. Sometimes associated with extraintestinal manifestations (joint, dermatological, ophthalmological or biliary systems), chronic inflammation of the digestive tract and the resulting symptoms (abdominal pain, diarrhea, rectal syndrome, etc.) lead to a significant alteration in the quality of life of patients in all spheres of activity (professional, sexual, social).

Sleep is a basic neurophysiological state, the normal total duration of which in humans is between six and ten hours per day. It is an essential element of the circadian rhythm in humans, influencing certain cellular functions and in particular the synthesis of cytokines and pro-inflammatory molecules (Nobel Prize in Medicine awarded to Jeffrey C. Hall, Michael Rosbash and Michael W. Young in 2017). Sleep disturbances and disruption of the circadian rhythm lead to metabolic and immunological dysfunctions, which may be involved in chronic inflammatory conditions through changes in the immune response.

In the field of IBD, many studies suggest poor sleep quality in patients with IBD. While there seems to be a link between sleep disorders and impaired quality of life with a socio-professional impact in these patients, the links between IBD activity, its treatment and sleep disorders are poorly studied, with discordant results in previous studies.

In order to enrich our knowledge on this topic, the investigators wish to study the prevalence and risk factors associated with sleep disorders in IBD patients in order to improve patients' quality of life

Clinical Trial Description

Objectives: The main objective of this work is to assess the prevalence of sleep disorders during IBD.

The secondary objectives are:

• Identify factors associated with sleep disorders

• To assess the association between sleep disturbances and IBD severity and activity

• To study the prevalence and weight of each of the 7 components of PSQI in the subgroup of patients with sleep disorders and their associated factors (clinical, activity and severity of inflammatory digestive disease, fatigue, quality of life and functional disability).

Material and Methods: Study Type: Interventional cross-sectional study in a hospital cohort

Population/patients:

Consecutive inclusion of all adult patients capable of consenting, followed for IBD in the hepato-gastroenterology department of the Reims University Hospital, a tertiary center with expertise in IBD.

Inclusion Criteria:

• Adult patients with Crohn's disease (CD) or ulcerative colitis (UC) presenting for consultation or hospitalization in Gastroenterology unit.

Non-inclusion criteria:

• Patients under legal protection

• Patients without social security coverage

• Pregnant women

Exclusion Criteria:

• Patients with an already identified sleep pathology

Investigation Plan:

Participation in the research will be offered to any eligible patient followed in Gastroenterology at the Reims University Hospital. If the patient agrees to participate in the research, he will be included in the study after receiving the information and signing the informed consent.

Once consent has been obtained, the patient will answer several (n=5) questionnaires, 3 self-questionnaires and 2 face-to-face questionnaires. If the patient wishes, he or she will be able to answer the 2 face-to-face questionnaires during a telephone interview, these questionnaires having been validated face-to-face as well as in a telephone interview.

The disease activity questionnaire will be either the "Clinical Mayo score" in UC or the "HBI" in CD.

• Specific self-questionnaires are the "Pittsburgh Sleep Quality Index" for sleep quality, "Functional Assessment of Chronic Illness Therapy by FACIT-F" for fatigue, and "Functional Disability by IBD-DI". They will be given to the patient at the end of the consultation and then retrieved after being completed.

• Specific face-to-face questionnaires are the "IBDQ" for quality of life, "HBI" or "Mayo clinical score" for disease activity will be completed during the consultation with the gastroenterologist, as part of the usual management.

• Clinical, biological, radiological, endoscopic and pathological data will be collected via the computerized patient file, and supplemented if necessary by a specifically developed standardized questionnaire. These data are essential to assess the extent of inflammatory digestive disease. The extent considered is the maximum extent of the disease in the patient's history, in fact no ad integrum restitution of the mucosa exists during the course of the patient's evolution.

The data will be pseudonymized and filled in by the first letter of the first and last name followed by a subsequent inclusion number.

Judging Criteria:

• Primary: Percentage of patients with a sleep disorder according to the PSQI questionnaire.

• Secondary outcomes will be:

• Disease activity according to HBI score for CD or clinical MAYO score for UC

• Fatigue according to FACIT-F score (Fatigue)

• Quality of life according to the IBDQ score (Inflammatory Bowel Disease Questionnaire)

• Functional disability according to IBD-DI (Inflammatory Bowel Disease - Disabilty Index) score

Investigation Plan:

Patients will be included in the consultation of physicians who are experts in IBD and hospitalization. The study will be explained to them by the expert gastroenterologist and after their inclusion they will complete the various questionnaires on their own and with a clinical research assistant for the face-to-face questionnaire (IBDQ) or over the phone with the clinical research assistant if they prefer.

Calculation of the number of patients to include:

This study is purely descriptive. All eligible patients will be notified of this study. The gastroenterology department of the Reims University Hospital is a reference centre with expertise in IBD.

The active queue is 1500 IBD patients seen in consultation or hospitalized in the gastroenterology department of the Reims University Hospital and the investigators hope to include at least 300 of them (20% of the entire active queue) over 1 year.

Statistics:

Data will be described using mean and standard deviation or median and interquartile range for quantitative variables and using size and percent for qualitative variables.

Normal-distributed continuous variables will be compared using Student's test. Variables with a non-normal distribution will be compared using the Mann-Whitney test. Discrete variables will be compared using Fisher's exact test or chi2, depending on the conditions of application.

The search for associated factors will be carried out by logistic regression.

Results and perspectives:

The purpose of this study is to estimate the prevalence of sleep disorders in the IBD population at Reims University Hospital, and to determine the potential factors associated with these sleep disorders, whether they are related to patients or digestive disease.

A better knowledge of the prevalence of these disorders could allow for appropriate management of affected patients, with a significant benefit on the quality of life of these patients. ;

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders
• Ulcerative Colitis

• NCT number: NCT06439641
• Study type: Interventional
• Source: CHU de Reims
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Completion date: September 2025