Prevalence of Sleep Disorder in Inflammatory Bowel Disease and Its Association With Disease Activity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Subjective sleep quality
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diagnosed inflammatory bowel disease, followed up in Siriraj hospital, Mahidol University
排除标准
- •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
结局指标
主要结局
Subjective sleep quality
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Julajak Limsrivilai
Associate professor
Mahidol University