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

Recruiting

• Conditions: Sleep Disorder; Inflammatory Bowel Diseases

• Registration Number: NCT05536817
• Lead Sponsor: Mahidol University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-05
• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-09-11
• Study First Posted: 2022-09-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective sleep quality	12 months	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.
Objective sleep quality	12 months	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.

Trial Locations

Locations (1)

Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand