Clincosm LogoSign in Get a demo

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

Sponsor
Mahidol University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05536817
Collaborator
(none)
100
Enrollment
1
Location
35.8
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prevalence of Sleep Disorder in Inflammatory Bowel Disease and Its Association With Disease Activity
    Actual Study Start Date :
    Feb 5, 2021
    Anticipated Primary Completion Date :
    Feb 1, 2023
    Anticipated Study Completion Date :
    Feb 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Julajak Limsrivilai, Associate professor, Mahidol University
    ClinicalTrials.gov Identifier:
    NCT05536817
    Other Study ID Numbers:
    • SI101/2021
    First Posted:
    Sep 13, 2022
    Last Update Posted:
    Sep 13, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Intestinal Diseases
    Inflammatory Bowel Diseases
    Sleep Wake Disorders
    Parasomnias

    Study Results

    No Results Posted as of Sep 13, 2022