Are Sleeping Disorders Associated With Visceral Hypersensitivity in Irritable Bowel Syndrome Patients ?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pressure threshold measured during the barostat procedure
研究概览
简要总结
Visceral hypersensitivity is frequent in IBS population up to 60% and is correlated with severity and altered quality of life. Sleeping troubles are most frequent in IBS population. Insomnia is a frequent disorder with an important cost for healthcare. Insomnia could decrease pain threshold.
Visceral hypersensitivity was never measure in patients with insomnia. The hypothesis is IBS patients with insomnia probably have lower visceral pain threshold.
The objective is to assess pain threshold during a barostat procedure in in IBS patients with or without insomnia in comparison with healthy volunteers or patients with insomnia.
If the hypothesis are confirmed, insomnia should be look at in IBS patients and its treatments could improve visceral hypersensitivity and IBS symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Healthy volunteers
- •- Person aged over 18 years with no IBS and no Insomnia
- •Patients with insomnia
- •- Patient aged over 18 years with no IBS and no Insomnia
- •Patients with IBS
- •- Patient aged over 18 years with IBS
- •patients with insomnia and IBS - Patient aged over 18 years with IBS
排除标准
- •Active chronic organic disease
- •Endometriosis
- •Opioids consumption
- •Change in chronic treatment in the last 30 days
- •Hypersensitivity to Normacol
- •Patient with blood dyscrasia disorder known or identified, anticoagulant or antiplatelet treatments
- •Rectal pathology
- •Intestinal occlusion
- •Severe renal failure
- •Sodium retention
- •Anal pathology (anal fissure, hemorrhoidal thrombosis)
- •Person with administrative or judicial decision or under legal protection measure
- •Patient participating in another trial in the last 30 days
- •Pregnant or breastfeeding women
- •Impossibility to keep fasting for 12 hours
研究组 & 干预措施
Patients with insomnia
干预措施: Assessment of sleep quality (Other)
Healthy volunteers
干预措施: Anxiety and Depression Evaluation (Other)
Healthy volunteers
干预措施: Assessment of sleep quality (Other)
Patients with irritable bowel syndrome
干预措施: Barostat procedure (Procedure)
Patients with irritable bowel syndrome
干预措施: Anxiety and Depression Evaluation (Other)
Patients with irritable bowel syndrome
干预措施: Assessment of sleep quality (Other)
Healthy volunteers
干预措施: Barostat procedure (Procedure)
Patients with irritable bowel syndrome and insomnia
干预措施: Barostat procedure (Procedure)
Patients with irritable bowel syndrome and insomnia
干预措施: Anxiety and Depression Evaluation (Other)
Patients with irritable bowel syndrome and insomnia
干预措施: Assessment of sleep quality (Other)
Patients with insomnia
干预措施: Barostat procedure (Procedure)
Patients with insomnia
干预措施: Anxiety and Depression Evaluation (Other)
结局指标
主要结局
Pressure threshold measured during the barostat procedure
时间窗: Day 35
Pressure threshold measured during the barostat procedure
次要结局
- Score at HAD anxiety and depression scale(Day 35)
- Score at Pittsburg sleep quality index(Day 35)