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临床试验/NCT04329091
NCT04329091终止4 期

Implications of Anesthetics on Sleep Consolidation

University of Chicago1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2020年10月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
9
试验地点
1
主要终点
Perceptual Learning Protocol

研究概览

简要总结

Sleep leads to consolidation of learning in humans, restoring memories that were forgotten over a waking day and protecting memories against future forgetting. Although theories of consolidation have linked sleep spindles seen on electroencephalography to consolidation due to their putative role in hippocampal transfer to the neocortex (Antony et al, 2019; Antony & Paller, 2017), spindles have not yet been linked to consolidation of perceptual learning or generalized learning. Prior research by a collaborator on this project has shown that sleep specifically aids in the consolidation of generalized perceptual learning of speech (Fenn, Nusbaum, & Margoliash, 2003). Subjects show a 10-point reduction in performance after a waking retention period, while no loss is found after a retention period containing sleep (Fenn et al., 2003).

Various measurable activities in the brain are associated with memory consolidation during sleep. This project intends study the effect of dexmedetomidine on memory consolidation during sleep

Hypothesis 1 The gain in perceptual learning after a 90 minute natural sleep nap will also occur after 90 minutes of a sufficient dose of IV dexmedetomidine to replicate sleep. This result would suggest that consolidation can occur under this anesthetic state of consciousness.

Hypothesis 2 The number and quality of sleep spindles seen on EEG in subjects administered dexmedetomidine will correlate with this gain in perceptual learning. This result would suggest that biomimetic sleep spindles are sufficient for producing memory consolidation.

Only those subjects capable of giving their own consent will be considered for this study.

The study will enroll 20 healthy subjects for this study between the ages of 18 and 35.

All volunteers will be fit and healthy, meeting the American Society of Anesthesiologists (ASA) physical status classification ASA 1 (normal healthy subjects) and ASA 2 (stable chronic condition) and of normal body habitus. Prior to the study enrollment, each volunteer will sign an informed consent form. A standard anesthetic medical history will be taken in addition to performing a focused standard pre-anesthetic physical examination in order to rule out active and chronic medical problems.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Dexmedetomidine Arm

Experimental

Dexmedetomidine: Administration of a 0.5 mcg/kg bolus followed by an infusion of 0.5-0.7 mcg/kg/hr, titrated up by 0.1 mcg every 1 minute until the subject spontaneously closes his or her eyes. When the subject spontaneously closes his or her eyes the infusion continues for 90 minutes from that point.

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Perceptual Learning Protocol

时间窗: 1 day

Subjects are tested in the morning for word recognition on hard-to-understand speech, then trained on this speech (never hearing the same words twice) which produces about 20 percentage points of improvement. After sedation subjects are re-tested. During the morning, afternoon and evening post-tests, subjects will be tested on new spoken words. At each time point where the perceptual learning protocol is administered the number of words correctly perceived out of 50 will be measured.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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