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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05536817

Enrollment

100

Registered

2022-09-13

Start date

2021-02-05

Completion date

2024-02-29

Last updated

2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases, Sleep Disorder

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Thailand

Contacts

Primary ContactJulajak Limsrivilai

alimsrivilai@gmail.com66814968895

Outcome results