Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis
Recruiting now
Conditions studied: Colitis, Ulcerative, Sleep Quality, Gastrointestinal Microbiome, Autonomic Nervous System Imbalance
In brief
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.
Key facts
- Study ID
- NCT06359808
- Run by
- Xijing Hospital
- People needed
- 152
- Starts
- 2024-04-01
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2025-12-31
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
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.).
Where it is running
- Xijing Hospital — Xi'an, Shaanxi, China (enrolling)
Full record on ClinicalTrials.gov
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