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

NCT ID: NCT05536817

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-05

Study Completion Date

2024-02-29

Brief Summary

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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

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Conditions

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Sleep Disorder Inflammatory Bowel Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Julajak Limsrivilai

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Julajak Limsrivilai

Role: CONTACT

[email protected]
66814968895

Facility Contacts

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Julajak Limsrivilai, MD

Role: primary

[email protected]
+66814968895

Other Identifiers

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SI101/2021

Identifier Type: -

Identifier Source: org_study_id