UCRecruiting

Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis

Observational · No treatment assigned · 1 site · Xijing Hospital

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

Condition(s) listed: Colitis, Ulcerative, Sleep Quality and Gastrointestinal Microbiome. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.

Who can join

Ages 18 to 65
Any sex
Healthy volunteers accepted

Some of the main requirements, copied from the record:

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.

There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 152 participants are expected to take part.
Start date: 2024-04-01.
Main results expected around 2026-06-30 (estimate from the record).
1 study site listed (1 marked recruiting) in China.

Main thing being measured

Pittsburgh Sleep Quality Index (PSQI) (At baseline)

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Observational
Study type	Observational
Conditions	Colitis, Ulcerative; Sleep Quality; Gastrointestinal Microbiome; Autonomic Nervous System Imbalance
Lead sponsor	Xijing Hospital
Enrollment	152 (estimated)
Start date	2024-04-01
Primary completion (est.)	2026-06-30
First posted	2024-04-11
Last updated	2025-12-31
Official title	A Study Based on the Microbiota-gut-brain Axis to Explore the Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis
ClinicalTrials.gov ID	NCT06359808

Interventions

None listed

Full eligibility criteria (from the record)

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.).

Locations (1)

Site	City	Country	Site status
Xijing Hospital	Xi'an, Shaanxi	China	Recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.