Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06439641 |
| Other study ID # |
PO24032* |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2024 |
| Est. completion date |
September 2025 |
Study information
| Verified date |
May 2024 |
| Source |
CHU de Reims |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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
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.
