Investigating sleep quality in patients with inflammatory bowel disease
Prevalence of Sleep Disorder in Inflammatory Bowel Disease and Its Association With Disease Activity
This study looks at how sleep quality is affected in people with inflammatory bowel disease to see if those with more active symptoms have worse sleep.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Locations | 1 site (Bangkok) |
| Trial ID | NCT05536817 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the prevalence of poor sleep quality among patients with inflammatory bowel disease (IBD) and its association with disease activity. A total of 100 participants will be classified based on their disease status as either active or inactive, using standard IBD severity assessment measures. Data will be collected through demographic surveys, disease activity assessments, quality of life evaluations, and validated sleep questionnaires, along with objective sleep data from wrist actigraphy over a week. The study will analyze the relationship between sleep quality and disease activity in IBD patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with inflammatory bowel disease who are being followed at Siriraj Hospital.
Not a fit: Patients with unstable medical conditions, known psychiatric diseases, or those who are pregnant or obese (BMI ≥ 35 kg/m2) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the relationship between sleep quality and IBD, potentially leading to improved management strategies for patients.
How similar studies have performed: While the association between sleep quality and IBD has been proposed, this specific observational approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Diagnosed inflammatory bowel disease, followed up in Siriraj hospital, Mahidol University Exclusion Criteria: * Unstable medical conditions * Known psychiatric disease * Patients who could not withhold sedative drugs * Pregnant patients * Obese patients with body mass index (BMI) ≥ 35 kg/m2 * Refuse to sign a consent/ had cognitive impairment
Where this trial is running
Bangkok
- Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University — Bangkok, Thailand (Recruiting)
Study contacts
- Study coordinator: Julajak Limsrivilai
- Email: alimsrivilai@gmail.com
- Phone: 66814968895
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.