Accuracy of Actigraph Measured Sleep Compared to Polysomnography During 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 Sleep data during acute uncomplicated diverticulitis (1-5th days following the admission) from baseline at remission (5th-30th days)
研究概览
简要总结
The purpose of this study is to investigate the accuracy of actigraph measured sleep compared to the golden standard (polysomnography) during Acute uncomplicated diverticulitis. Our hypothesis is the actigraph is accurate for sleep-monitoring for this group of patients
详细描述
The actigraph has been proven to measured sleep data with an accuracy about 80% (compared with Polysomnography) in patients who have undergone surgery.
But this accuracy has not been validated in relation to none surgical inflammatory diseases. This study will investigate the accuracy of actigraph measured sleep in diverticulitis patients.
Following methods will be applied
Device: Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA
Other: Sleep-diary
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 Sleep data during acute uncomplicated diverticulitis (1-5th days following the admission) from baseline at remission (5th-30th days)
时间窗: 1st-30th days following the admission
Sleep measured by Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings). A wrist actigraph wil be worn from 1st day of the admission and taken off on the 31st day.
Changes in Circadian rhythm during acute uncomplicated diverticulitis (1-5th days following the admission) from baseline at remission (5th-30th days)
时间窗: 1st-30th days following the admission
Circadian rhythm measured by Actigraphy. A wrist actigraph wil be worn from 1st day of the admission and taken off on the 31st day.
Accuracy of actigraphy measured sleep data in compare to Polysomnography both in inflammatory condition and in remission condition
时间窗: 1st, 2nd and 30th days following the admission
Sleep data measured by Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings) are to validate with the PSG-measured data
次要结局
未报告次要终点
研究者
Ismail Gögenür
Senior resident and D.Sc.
Herlev Hospital