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

May 2, 2025 updated by: CHU de Reims

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

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. 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • Chu Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with an identified sleep pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with Inflammatory bowel diseases
patients with IBD
Other: Ulcerative colitis Disease Activity Index
QUESTIONNAIRE - Score between 0 to 12, the higher is the worse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index Questionnaire
Time Frame: Only one time at inclusion
Score between 0 to 12, the higher is the worse
Only one time at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2024

Primary Completion (Actual)

November 26, 2024

Study Completion (Actual)

May 2, 2025

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO24032*

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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