Effect of sleep disturbance on disease outcome in inflammatory bowel disease patients with clinical remission: a prospective cohort study

• Conditions: Disease flare up in inflammatory bowel disease patients with or without sleep disturbance; Inflammatory bowel disease, Sleep, polysomnography, Clinical outcome

• Registration Number: TCTR20230321008
• Lead Sponsor: Gastroenterology unit, King Chulalongkorn Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-21
• Study Completion: 2023-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

IBD patients with clinical remission (no drug adjustment for more than 2 months and use steroids less than or equal to 10 mg per day)

Exclusion Criteria

1. Pregnancy or Lactating
2. Patient with stoma
3. Shift workers
4. Active cancer
5. Obstructive sleep apnea syndrome that required continuous positive airway pressure, obstructive sleep apnea syndrome with apnea-hypopnea index more than 30 episodes per hour

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease flare up within 6 months Score (CDAI, pMayo score), Hospitalization/Surgery related to IBD

Secondary Outcome Measures

Name	Time	Method
Disease flare up within 12 months Score (CDAI, pMayo score), Hospitalization/Surgery related to IBD