About this trial
Ulcerative colitis(UC) is one of the two main forms of inflammatory bowel disease(IBD), which seriously affects the quality of life of patients. Previous studies have demonstrated that more than 60% of IBD patients have sleep disorders, which is emerging as an important risk factor for disease recurrence and poor prognosis. However, the mechanisms by which sleep disorders regulates the occurrence and development of IBD remain undefined. This study aims to explore the clinical characteristics of ulcerative colitis patients with sleep disorders based on the microbiota-gut-brain axis, to analyze the effects of sleep disorders on autonomic nervous function, gut microbiota, and metabolites in UC patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ulcerative colitis was diagnosed according to the Consensus Opinions on the Diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018);
Complete medical records and signed informed consent.
Disqualifiers
Previous mental illness or taking anti-anxiety and depression drugs;
Patients with malignant tumors of digestive system or serious diseases of organs such as heart, lung, liver and kidney function damage or diseases of blood system;
Drugs that affect heart rate or autonomic nervous function, such as glucocorticoids, beta-blockers, calcium channel blockers, etc. have been taken within the last 2 weeks;
People who smoke, drink alcohol, drink tea, and drink coffee within 24 hours (all stimulants, which can easily lead to excitement and affect heart rate variability);
Trial population
Ulcerative colitis patients aged 18-65 years were recruited from The First Affiliated Hospital of the Air Forth Medical University.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Pittsburgh Sleep Quality Index (PSQI)
PSQI is used to evaluate the sleep quality of the subjects in the last 1 month. There are 7 dimensions and 9 entries with a total score between 0 and 21, where a score higher than 5 indicates a sleep quality problem, 0 to 5 indicates good sleep quality, 6 to 10 indicates moderate sleep quality, 11 to 15 indicates poor sleep quality, and 16 to 21 indicates very poor sleep quality.
Disease activity
The modified Mayo score and calprotectin are used to assess the disease activity of ulcerative colitis patients.
Heart Rate Variability (HRV)
HRV reflects the continuous oscillations of the R-R intervals between normal heartbeats and is strongly correlated with actual vagal nerve activity. HRV thus provides a noninvasive and quantitative index of parasympathetic nervous system activity.
Functional Magnetic Resonance Imaging
Resting-state functional MRI (rs-fMRI) is a noninvasive imaging modality that is able to measure spontaneous low-frequency blood oxygen level-dependent signal fluctuations at rest to infer neuronal activity.
Secondary outcomes
Patient Health Questionnaire (PHQ-9)
PHQ-9 is a widely used international universal depression screening scales. It consists of nine main entries, each with a score of 0 to 3 and a total score between 0 and 27.
Generalized Anxiety Disorder (GAD-7)
GAD-7 is a widely used anxiety screening scales. It includes 7 entries, each with a score of 0 to 3 and a total score between 0 and 21.
Inflammatory Bowel Diseases Questionnaire (IBDQ)
IBD-Q has been widely used to evaluate the quality of life of IBD patients, including 4 dimensions of bowel symptoms, systemic symptoms, emotional ability, and social ability, with a total of 32 items.18 Each item is divided into 7 levels, counting from 1 to 7, with 1 indicating the most severe degree and 7 indicating the least severe degree. The total score ranged from 32 to 224, and the higher the total score, the better the patient's quality of survival.
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