Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorXijing Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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);

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

152 Participants
are grouped into 2 trial groups
Group A: Ulcerative colitis group
Group B: Healthy subjects

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline
2

Disease activity

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

Time frame
At baseline
3

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.

Time frame
At baseline
4

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.

Time frame
At baseline

Secondary outcomes

1

Patient Health Questionnaire (PHQ-9)

PHQ-9 is a widely used international universal depression screening scales. It consists of nine main entries, each with a score of 0 to 3 and a total score between 0 and 27.

Time frame
At baseline
2

Generalized Anxiety Disorder (GAD-7)

GAD-7 is a widely used anxiety screening scales. It includes 7 entries, each with a score of 0 to 3 and a total score between 0 and 21.

Time frame
At baseline
3

Inflammatory Bowel Diseases Questionnaire (IBDQ)

IBD-Q has been widely used to evaluate the quality of life of IBD patients, including 4 dimensions of bowel symptoms, systemic symptoms, emotional ability, and social ability, with a total of 32 items.18 Each item is divided into 7 levels, counting from 1 to 7, with 1 indicating the most severe degree and 7 indicating the least severe degree. The total score ranged from 32 to 224, and the higher the total score, the better the patient's quality of survival.

Time frame
At baseline

Other outcomes

Sponsors and contacts

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