Evaluation of Sleep Changes as Early Markers of Relapse in Patients With Inflammatory Bowel Diseases (IBD).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 8
- 主要终点
- rate of relapse
研究概览
简要总结
Inflammatory Bowel Diseases (IBD) go through two phases: flare and remission. Prediction of flares and identification of patients in remission but at high risk of flare are a major issue when taking care of IBD patients.
Considering close interactions between sleep, immunity and intestinal inflammation, sleep disorders could be a predictor of flares.
The purpose of this study is to demonstrate that sleep efficacy decreases before IBD flare.
Patients in remission will be assessed for IBD symptoms (activity scores, biological factors) and sleep disorders (actigraphy, DREEM®, questionnaires) during one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 and under 65 years of age.
- •Patient with Inflammatory Bowel Disease diagnosed for at least 3 months.
- •Patient in remission, for at least 3 months:
- •clinical remission: Harvey-Bradshaw score (HBI) < 5 for CD and a Mayo score < 3 for UC
- •and biological remission: absence of objective inflammation defined by CRP < 5 mg/L and/or fecal calprotectin < 250 µg/g.
- •Patient must sign informed consent form to participate to the study.
- •Patient affiliated to or benefiting from a social security plan.
排除标准
- •Patient with complications (obstructive symptoms, fistulas or intra-abdominal abscesses in the previous three months).
- •Patient with extensive bowel resection (> 40 cm of small bowel).
- •Patient with an ileostomy or colostomy.
- •Patient diagnosed with sleep disorders.
- •Patient without legal capacity to consent.
- •Pregnant, parturient or nursing women.
- •Persons deprived of liberty by judicial or administrative decision.
- •Persons under psychiatric care.
- •Persons admitted to a health or social institution for purposes other than research.
- •Persons of full age who are subject to a legal protection measure (guardianship, curators).
结局指标
主要结局
rate of relapse
时间窗: 12 months after baseline
For Crohn's disease: Harvey Bradshaw Index ≥ 5 AND a CRP \> 5 mg/L and/or calprotectin \> 250 µg/g For ulcerative colitis: Mayo ≥ 3 AND a CRP \> 5 mg/L and/or calprotectin \> 250 µg/g Sleep efficiency will be measured by actimetry and expressed as a percentage. Sleep efficiency is defined as the ratio of total time spent asleep compared to total time spent in bed. An actinometer will collect one efficiency measurement per night; an average per week will then be calculated from the daily measurements.
次要结局
- intra-sleep wake duration(12 months after baseline)
- polysomnographic sleep efficiency(12 months after baseline)
- Sleep efficiency calculated by actimetry and expressed in percentage.(12 months after baseline)
- sleep onset latency(12 months after baseline)
- Intra-sleep wakefulness duration (min), sleep latency (min) and sleep duration (min)(12 months after baseline)
- index of micro-arousals(12 months after baseline)
- total sleep time(12 months after baseline)
- delta spectral power in slow wave sleep(12 months after baseline)
- quantity of different sleep stages(12 months after baseline)
- spindle density(12 months after baseline)