NCT06359808 Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis
| NCT ID | NCT06359808 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xijing Hospital |
| Condition | Colitis, Ulcerative |
| Study Type | OBSERVATIONAL |
| Enrollment | 152 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 152 participants in total. It began in 2024-04-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.).
Contact & Investigator
Kaichun Wu
PRINCIPAL INVESTIGATOR
Xijing Hospital
Frequently Asked Questions
Who can join the NCT06359808 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Colitis, Ulcerative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06359808 currently recruiting?
Yes, NCT06359808 is actively recruiting participants. Contact the research team at 1041181972@qq.com for enrollment information.
Where is the NCT06359808 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT06359808 clinical trial?
NCT06359808 is sponsored by Xijing Hospital. The principal investigator is Kaichun Wu at Xijing Hospital. The trial plans to enroll 152 participants.