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临床试验/NCT04602988
NCT04602988进行中(未招募)不适用

Continuous, Non-Invasive Monitoring of Mental Status

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2020年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
350
试验地点
1
主要终点
EEG

研究概览

简要总结

A mainstay in the diagnosis and care of hospitalized patients is the assessment of mental status. Changes in mental status can have broad clinical significance, and while some patients are admitted with mental status changes, nearly half of the patients who experience delirium in the hospital develop it after admission in a manner that is hard to predict on the level of individual patients. Patients with altered mental status such as delirium have worse clinical outcomes, suggesting that early monitoring of mental status can identify important clinical populations who may benefit from targeted delirium prevention and intervention. Delirium remains under-recognized in the hospital, in part due to its fluctuating nature. Typically, mental status is assessed sporadically, perhaps once a day, through intermittent and subjective clinical interactions. As such, there is a clear clinical need for objective, continuous methods to monitor mental status. Such methods could potentially improve detection of delirium, potentially even predicting it prior to clinical recognition, and therefore direct multimodal delirium prevention and intervention strategies when most effective-before delirium becomes fully manifest. In this proposal we plan on testing noninvasive, continuous monitors of mental status in the inpatient setting, primarily through the use of EEG.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to a general medical ward
  • Expected stay of at least one night

排除标准

  • patients who have any scalp incisions or head wound(s) that would prevent EEG attachment
  • Non-English speakers

结局指标

主要结局

EEG

时间窗: Daily during the time of EEG recording up to 7 days

Relative EEG power in the delta \& theta bands

Delirium Severity

时间窗: Daily during the time of EEG recording up to 7 days

Inpatient Delirium as assessed by the 3D-CAM-S

次要结局

  • Functional status(3 months after completion of EEG recording)

研究者

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

Eyal Y. Kimchi, M.D.,Ph.D.

Assistant Professor

Massachusetts General Hospital

研究点 (1)

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