Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439641
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-28
Brief Title:
Prevalence and Factors Associated With Sleep Disorders in Inflammatory Bowel Disease
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Prevalence and Factors Associated With Sleep Disorders in Inflammatory Bowel Disease a Cross-sectional Study at Reims University Hospital
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOMMICI
Brief Summary:
Inflammatory bowel diseases IBD including Crohns 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
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
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
Populationpatients
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 Crohns 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 n5 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 patients history in fact no ad integrum restitution of the mucosa exists during the course of the patients 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 Students test Variables with a non-normal distribution will be compared using the Mann-Whitney test Discrete variables will be compared using Fishers 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
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
Populationpatients
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 Crohns 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 n5 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 patients history in fact no ad integrum restitution of the mucosa exists during the course of the patients 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 Students test Variables with a non-normal distribution will be compared using the Mann-Whitney test Discrete variables will be compared using Fishers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None