Sleep Disorder in Inflammatory Bowel Disease and Its Association With Disease Activity

Inflammatory Bowel Diseases Clinical Trial

Official title:

Prevalence of Sleep Disorder in Inflammatory Bowel Disease and Its Association With Disease Activity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05536817
• Other study ID #: SI101/2021
• Status: Recruiting
• Start date: February 5, 2021
• Est. completion date: February 2024

Study information

• Verified date: November 2023
• Source: Mahidol University
• Contact: Julajak Limsrivilai
• Phone: 66814968895
• Email: alimsrivilai[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Recently, an association between active inflammatory bowel disease (IBD) and poor sleep quality has been proposed; however, the causal relationship has not yet been established. This study aimed to investigate prevalence of poor sleep quality in IBD and association with disease activity by subjective and objective measures.

Prospective observational study is conducted with expected sample size of 100 patients. Participants are classified into active and inactive disease status according to standard IBD severity assessment measures. Demographic data, disease activity, quality of life, sleep questionnaire (validated PSQI questionaire), and seven-day sleep data acquired from ambulatory wrist actigraphy were obtained. Association between sleep quality and disease activity will be analyzed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Locations

Country	Name	City	State
Thailand	Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective sleep quality	PSQI (Pittsburg sleep questionaire index) scores at first day then every month. PSQI contains ten questions, scoring provides sleep duration, latency, disturbance, efficiency, and quality. Total PSQI score of > 5 indicates poor sleep quality.	12 months
Primary	Objective sleep quality	Sleep efficiency (percentage of total sleep time compared to time-in-bed) provided by ambulatory wrist actigraphy on first seven consecutive days and at 12-month period. Score less than 85% is considered poor sleep quality.	12 months