Exploring sleep disorders in ulcerative colitis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the clinical characteristics of patients with ulcerative colitis (UC) who experience sleep disorders. It aims to analyze the impact of sleep quality on the autonomic nervous system, gut microbiota, and metabolites in UC patients. A total of 152 UC patients will be recruited, and their sleep quality will be assessed using the PSQI scale. The study will also evaluate disease activity through Mayo scores and fecal calprotectin levels, while comparing findings with age-, gender-, and education-matched healthy controls.

Why it matters

Who can join: the full rules

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.).

Where it's running

• Xijing Hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Principal investigator: Kaichun Wu — Xijing Hospital
• Study coordinator: Jiaming Zhou
• Email: 1041181972@qq.com
• Phone: +86 173 9207 9496

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.