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Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis

NCT ID: NCT06359808

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colitis, Ulcerative Sleep Quality Gastrointestinal Microbiome Autonomic Nervous System Imbalance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Ulcerative colitis group

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.

No interventions assigned to this group

Healthy subjects

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.

No interventions assigned to this group

Eligibility Criteria

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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.).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kaichun Wu

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiaming Zhou

Role: CONTACT

Phone: +86 173 9207 9496

Email: [email protected]

Facility Contacts

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Jiaming Zhou

Role: primary

Other Identifiers

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KY20232370

Identifier Type: -

Identifier Source: org_study_id