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临床试验/NCT03498560
NCT03498560已完成不适用

Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Association Between Sleep and POD

研究概览

简要总结

The investigators are performing this research study to understand the role of sleep disturbance on the incidence/severity of delirium after surgery. The investigators will study the brain using a polysomnography device (PSG), which records the brain's electrical activity during sleep.

详细描述

During this study, PSG recordings will be collected and a sleep questionnaire will be administered to participants on the night before surgery in order to establish level of preexisting sleep disturbance. Delirium assessments will be conducted during the postoperative period. On postoperative days 0 and 1, blood will be collected for analysis. Further cognitive, quality of life and pain questionnaires will be administered perioperatively.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 60 years of age
  • Inpatient and scheduled for surgical procedure at MGH

排除标准

  • Blindness, deafness or the inability to speak English
  • Inability to provide informed consent
  • Objective Drop Criteria
  • Post-operative intubation greater than 24 hours

结局指标

主要结局

Association Between Sleep and POD

时间窗: Night before surgery, approximately 13 hours

Duration of sleep in delirious vs non-delirious patients

次要结局

  • Burst Suppression Ratio(Length of surgery (2-12 hours))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oluwaseun Johnson-Akeju, MD, MMSc

Associate Professor of Anaesthesia

Massachusetts General Hospital

研究点 (1)

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