the Effects of Inflammatory Cytokines on Sleep During Acute Diverticulitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- change in Sleep architecture during acute uncomplicated diverticulitis from baseline at the remission (30th day)
研究概览
简要总结
The purpose of this study is to investigate sleep disturbances during Acute uncomplicated diverticulitis by polysomnography. The investigators hypothesis is the inflammation causes REM(rapid eye movement)-sleep reduction and this is correlated with plasma cytokine levels.
详细描述
An increasing number of experimental studies have showed that inflammation can induce disturbances in sleep architecture, mediated by cytokines. Sleep is important both in health and disease processes and can affect recovery, morbidity and mortality.
Studies have been done on sleep disturbances after major and minor GI-surgery but never in relation to none surgical inflammatory diseases, namely acute diverticulitis.
This study will investigate sleep architecture by Polysomnography and inflammation by levels of pro inflammatory cytokines in plasma.
Following methods will be applied
Device: Polysomnograph - Embla Titanium (Natus Medical Incorporated, USA)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CT-verified diverticulitis patients managed by antibiotic treatment at Herlev Hospital
- •Pain and fever occurred less than 72 hours prior to the admission
- •ASA (American Society of Anesthesiologists) score I to III
排除标准
- •Surgical intervention needed
- •Complicated diverticulitis
- •Complications in relation to diverticulitis
- •Pain and fever occurred more than 72 hours prior to the admission
- •In anticoagulant treatment and heart rate control treatment
- •Known Autoimmune disease
- •Known medically treated sleep-disorder (insomnia, restless legs etc.) and sleep apnea
- •Shift-work or jetlag
- •Daily use of opioid, psychopharmaca, opioids or anxiolytics (including Hypnotics)
- •Known psychiatry conditions in treatment with psychopharmaca
- •Daily alcohol intake of more than 5 units or drug abuse
- •Missing written consent
- •Diabetes Mellitus
- •Predicted bad compliance
- •Pregnant or breast-feeding
- •Urine or fecal incontinence
- •Severe kidney disease
- •Current cancer
结局指标
主要结局
change in Sleep architecture during acute uncomplicated diverticulitis from baseline at the remission (30th day)
时间窗: 1st, 2nd and 30th nights following the admission
Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings)
change in cytokine levels in plasma during the acute uncomplicated diverticulitis from baseline levels at remission
时间窗: 1st, 2nd and 30th nights following the admission
the Blood sample is taken prior to night sleep; Cytokines are measured by commercial ELISA-kits
change in CRP level in plasma during the acute uncomplicated diverticulitis from baseline levels at remission
时间窗: 1st, 2nd and 30th nights following the admission
the Blood sample is taken prior to night sleep; CRP is measured by standardized conventional method
change in leucocyte level in plasma during the acute uncomplicated diverticulitis from baseline levels at remission
时间窗: 1st, 2nd and 30th nights following the admission
the Blood sample is taken prior to night sleep; Leucocyte is measured by standardized conventional method
次要结局
未报告次要终点
研究者
Ismail Gögenür
Senior resident and D.Sc.
Herlev Hospital