Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Colitis, Ulcerative; Autonomic Nervous System Imbalance; Sleep Quality; Gastrointestinal Microbiome

Study type: Observational

Funder types: Other

Identifiers

NCT06359808

KY20232370

Details and patient eligibility

About

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.

Full description

According to the inclusion and exclusion criteria, 152 UC patients of the First Affiliated Hospital of the Air Forth Medical University from April 2024 to December 2024 will be included. The PSQI scale was used to evaluate the sleep quality of the enrolled patients, and the overall incidence and severity of sleep disorders in UC patients will be evaluated. According to whether the PSQI score is higher than 5 points, the subjects will be divided into UC with sleep disorder group and the UC without sleep disorder group. By reviewing electronic medical records and questionnaire surveys, general clinical information of the subjects will be collected to analyze the risk factors of sleep disorders in UC patients. Mayo score and fecal calprotectin levels will be used to assess disease activity. The correlation between sleep disorders and disease activity in UC patients will be evaluated. Age-, gender-, and education level-matched healthy controls will be recruited from The First Affiliated Hospital of the Air Forth Medical University from April 2024 to December 2024. Heart rate variability will be measured to evaluate vagal nerve activity. Serum pancreatic peptide, norepinephrine, acetylcholine, and serotonin will be measured to evaluate serum neurotransmitter levels, and resting state functional magnetic resonance imaging will be used to evaluate the brain functional activity area of the subjects. Differences and correlations in autonomic nervous system function between UC with sleep disorder and UC without sleep disorder will be explored. 16s sequencing and metabolomics will be used to analyze changes in gut microbiota and metabolites. The correlation between gut microbiota and metabolites and sleep disorders in UC patients will be explored.

Enrollment: 152 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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);
• Other diseases associated with autonomic nervous dysfunction (such as hyperthyroidism, hypertension, atrial premature beat, ventricular premature beat, pre-excitation syndrome, left bundle branch block, right bundle branch block, etc.).

Trial design

152 participants in 2 patient groups

Ulcerative colitis group

Description:

Ulcerative colitis patients aged 18-65 years will be recruited from The First Affiliated Hospital of the Air Forth Medical University from April 2024 to December 2024.

Healthy subjects

Description:

Age-, gender-, and education level-matched healthy controls will be recruited from The First Affiliated Hospital of the Air Forth Medical University from April 2024 to December 2024.