Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis

NCT06359808 | Recruiting

• 1 other identifier: KY20232370
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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.

  At baseline

• Disease activity

  The modified Mayo score and calprotectin are used to assess the disease activity of ulcerative colitis patients.

  At baseline

• 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.

  At baseline

• 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.

  At baseline

• Neurotransmitter Agents

  Serotonin, Pancreatic Polypeptide, Norepinephrine and Acetylcholine will be tested.

  At baseline

• Gastrointestinal Microbiome

  Fecal samples of some participants will be collected and prepared. DNA will be extracted from the stool samples, and the V3-V4 hypervariable region of bacterial 16S rRNA gene was sequenced.

  At baseline

Secondary Outcomes (3)

• Patient Health Questionnaire (PHQ-9)

  At baseline

• Generalized Anxiety Disorder (GAD-7)

  At baseline

• Inflammatory Bowel Diseases Questionnaire (IBDQ)

  At baseline

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ulcerative colitis patients aged 18-65 years were recruited from The First Affiliated Hospital of the Air Forth Medical University.

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fecal, plasma and fixed tissue samples of some participants will be collected.

MeSH Terms

Conditions

Colitis, Ulcerative; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Kaichun Wu

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaming Zhou

CONTACT

+86 173 9207 9496; 1041181972@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 11, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

CN (1)