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

M

Mahidol University

Status

Enrolling

Conditions

Sleep Disorder
Inflammatory Bowel Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT05536817
SI101/2021

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Julajak Limsrivilai

Data sourced from clinicaltrials.gov

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