Subjective Sleep Quality and Fatigue During and After Acute Uncomplicated 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
- Changes in pain during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day)
研究概览
简要总结
The purpose of this study is to investigate subjective sleep quality and fatigue during and after Acute uncomplicated diverticulitis assessed by questionnaires and a sleep-diary. The investigators hypothesis is that subjective sleep and fatigue are correlated with the inflammatory activities.
详细描述
An increasing number of experimental studies have showed that inflammation can induce disturbances in sleep architecture, mediated by cytokines. some studies showed that cytokines also induce daytime fatigue. In this study the investigators aim to describe the patient experiences of sleep and fatigue during the acute inflammation and the recovery, and the investigators seek to exam the correlation of fatigue with Polysomnography-measured night sleep and cytokine levels in plasma.
Following methods will be applied
- Other: Karolinska Sleepiness Scale
- Other: Physical Fatigue Scale
- Other: Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain
- Other: Sleep-diary
- Device: Polysomnograph - Embla Titanium (Natus Medical Incorporated, USA)
- Procedure: Plasma cytokines (IL-2, IL-6 and TNF-alfa(tumor necrosis factor))
- Procedure: Plasma CRP(C reactive protein) and leukocytes
- Device: Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, 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
Changes in pain during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day)
时间窗: 1st-10th day and 14th, 21st, 30th day following the admission
Pain measured on VAS
Changes in Sleep quality during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day)
时间窗: 1st-10th day and 14th, 21st, 30th day following the admission
1. subjective sleep quality measured by a Visual Analog Scale (VAS) at given time frame 2. sleep-diary recording sleep quantity of day and night sleep at given time frame
Changes in Sleepiness during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day)
时间窗: 1st-10th day and 14th, 21st, 30th day following the admission
Sleepiness measured by Karolinska Sleepiness Scale at given time frame
Changes in fatigue during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day)
时间窗: 1st-10th day and 14th, 21st, 30th day following the admission
1. General fatigue measured on Visual Analog Scale at given time frame 2. Physical fatigue measured on a 10 points scale at given time frame
Changes in general well-being during acute uncomplicated diverticulitis from baseline score at remission (14th, 21st and 30th day)
时间窗: 1st-10th day and 14th, 21st, 30th day following the admission
general well being measured on VAS
次要结局
- accuracy of sleep diary compared to actigraph in measuring sleep data(1st-10th day and 14th, 21st, 30th day following the admission)
- correlation between sleepiness and level of cytokines in patient's plasma(1st and 2nd and 30th day following the admission)
- correlation between pain and level of cytokines in patient's plasma(1st and 2nd and 30th day following the admission)
- accuracy of sleep diary compared to Polysomnography (PSG) in measuring sleep data(1st-2nd day and 30th day following the admission)
- correlation between fatigue and level of cytokines in patient's plasma(1st and 2nd and 30th day following the admission)
- correlation between general well-being and level of cytokines in patient's plasma(1st and 2nd and 30th day following the admission)
研究者
Ismail Gögenür
Senior resident and D.Sc.
Herlev Hospital