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临床试验/NCT06439641
NCT06439641已完成不适用

Prevalence and Factors Associated With Sleep Disorders in Inflammatory Bowel Disease: a Cross-sectional Study at Reims University Hospital

CHU de Reims2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
300
试验地点
2
主要终点
Pittsburgh Sleep Quality Index Questionnaire

研究概览

简要总结

Inflammatory bowel diseases (IBD) including Crohn's disease (CD) and ulcerative colitis (UC), are an inflammatory disease that can affect the entire digestive tract from the mouth to the anus for CD and the entire colon and rectum for UC. They mainly affect adolescents and young adults. These pathologies evolve in relapses interspersed with phases of remission. Sometimes associated with extraintestinal manifestations (joint, dermatological, ophthalmological or biliary systems), chronic inflammation of the digestive tract and the resulting symptoms (abdominal pain, diarrhea, rectal syndrome, etc.) lead to a significant alteration in the quality of life of patients in all spheres of activity (professional, sexual, social).

Sleep is a basic neurophysiological state, the normal total duration of which in humans is between six and ten hours per day. It is an essential element of the circadian rhythm in humans, influencing certain cellular functions and in particular the synthesis of cytokines and pro-inflammatory molecules. Sleep disturbances and disruption of the circadian rhythm lead to metabolic and immunological dysfunctions, which may be involved in chronic inflammatory conditions through changes in the immune response.

In the field of IBD, many studies suggest poor sleep quality in patients with IBD. While there seems to be a link between sleep disorders and impaired quality of life with a socio-professional impact in these patients, the links between IBD activity, its treatment and sleep disorders are poorly studied, with discordant results in previous studies.

In order to enrich our knowledge on this topic, the investigators wish to study the prevalence and risk factors associated with sleep disorders in IBD patients in order to improve patients' quality of life

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with Crohn's disease (CD) or ulcerative colitis (UC) presenting for consultation or hospitalization in Gastroenterology unit

排除标准

  • Patients with an identified sleep pathology

结局指标

主要结局

Pittsburgh Sleep Quality Index Questionnaire

时间窗: Only one time at inclusion

Score between 0 to 12, the higher is the worse

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (2)

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