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临床试验/NCT03572920
NCT03572920已完成不适用

Actigraphy-based RAR and Sleep Behavior in Hospitalized Patients for Hip/Knee Prosthesis

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年6月19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
入组人数
20
试验地点
1
主要终点
Sleep Efficiency (SE) by actigraphy

研究概览

简要总结

The consequences of chronically insufficient sleep are both behavioral and medical. . Patients who undergo total knee or hip arthroplasty commonly complain of sleep fragmentation after hospitalization The aim of the present study is to evaluate the changes inrest-activity circadian rhythm (RAR) and objective and subjective sleep quality and perceived pain, untill the 10th hospitalization day, in patients who underwent total knee or hip arthroplasty.

详细描述

The National Health and Nutrition Examination Survey found that 22% of the US population reported 6 h of sleep or less and another 15% registered 5 h of sleep or less per 24 h (1). The consequences of chronically insufficient sleep are both behavioral and medical. Quantity and quality of sleep represent important factors for the quality of life, which can have positive or negative influence on individual health (2-4). Patients who undergo total knee or hip arthroplasty commonly complain of sleep fragmentation after hospitalization (5,6) Such patients experience acute postsurgical pain and discomfort, including restriction of their leg movement to prevent dislocation of the hip implant in the acute stage. The results of previous post-surgery studies have shown that REM sleep was severely reduced and awake time increased on the first postoperative night compared with the preoperative night (7,8).It is necessary for patients to secure the appropriate amount and quality of sleep to facilitate recuperation after surgery. Sleep disturbance is also related to the presence of delirium. The aim of the present study is to evaluate the changes in objective and subjective sleep quality and perceived pain, untill the 10th hospitalization day, in patients who underwent total knee or hip arthroplasty.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male of female subjects aged between 50 and 80 years old.
  • Knee or Hip Arthroplasty at IRCCS Galeazzi Orthopedic Institute.
  • Cognitively intact
  • Inclusion in the rehabilitation program within the Orthopedic Specialist Rehabilitation Unit of IRCCS Galeazzi Orthopedic Institute.
  • Informed signed consent.

排除标准

  • Cancer history.
  • Body Mass Index < 18.5 e > 40.
  • Melaton consumption.
  • Previous clinical sleep disorders.

结局指标

主要结局

Sleep Efficiency (SE) by actigraphy

时间窗: At baseline untill 10th hospitalization day.

The percentage of time in bed spent actually sleeping.

Sleep Latency (SL) by actigraphy

时间窗: At baseline untill 10th hospitalization day.

The period of time required for sleep onset after retiring to bed.

Pittsburgh Sleep Quality Index (PSQI) questionnaire

时间窗: At baseline and at the 10th hospitalization day.

Evaluation of habitual sleep quality trough a validated questionnaire. 19 items where each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

Assumed Sleep (AS) by actigraphy

时间窗: At baseline untill 10th hospitalization day.

The difference in hours and minutes between the Sleep end and Sleep start times.

Epworth Sleepiness Scale (ESS)

时间窗: Every day, from baseline untill the 10th hospitalization day.

Evaluation of daytime sleepiness. 7 item and each item is weighted on a 0-3 interval scale. Range scores from 0 to 21. Higher scores correspond to higher sleepiness status during the day.

Rest-activty Circadian rhythm (RAR) by actigraphy

时间窗: At baseline untill 10th hospitalization day.

The 24-hrs daily rhythm of activity levels.

次要结局

未报告次要终点

研究者

发起方
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
申办方类型
Other
责任方
Sponsor

研究点 (1)

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