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临床试验/NCT03304652
NCT03304652已完成不适用

Cerebral MRI During Sleep

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年10月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Cerebral MRI Changes

研究概览

简要总结

Recent studies in animal models have suggested a critical role for cerebrospinal fluid and Interstitial fluid flux through cerebral parenchyma for removal of byproducts of cellular metabolism and hence in maintaining the health of the brain. This effect is modulated during sleep, suggesting a potentially important mechanism for sleep to maintain both acute homeostasis and long-term cerebral health.

The central goal of these studies is to develop a sensitive MRI biomarker of cerebral conformational changes during sleep. This exploratory work aims to establish the sensitivity and reproducibility of MRI as a non-invasive neuroimaging assessment of cerebral changes during natural sleep and sedation.

详细描述

Recent studies in animal models have suggested a critical role for cerebrospinal fluid (CSF) / Interstitial fluid (ISF) flux through cerebral parenchyma for removal of byproducts of cellular metabolism and hence in maintaining the health of the brain. It remains unknown to what extent these phenomena exist in the human brain. A key challenge in this work is to make non-invasive and reproducible measurements of the cerebral microenvironment in humans. For these studies, the investigators have implemented a suite of MRI measurements to track physiological changes in the brain during sleep. This exploratory work aims to establish the sensitivity and reproducibility of MRI as a non-invasive neuroimaging assessment of cerebral changes during natural sleep and sedation. The long term goal of this work is to use MRI as an imaging biomarker to assess the cerebral response to normal versus disordered sleep in patients.

Our specific aims will address the following questions:

Aim 1: How sensitive are MRI metrics for determining changes in the brain during sleep?

Aim 2: How reproducible are MRI metrics during sleep and during sedation?

The investigators will recruit 12 normal adult subjects for this study (consecutive respondees to recruitment adverts). The investigators will make regional MRI measurements during onset, maintenance and waking from stage N2 sleep. From these the investigators will characterize which MRI metrics are most sensitive to changes in the cerebral environment, and how these vary for different cerebral regions.

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 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy Adults

排除标准

  • age not in range 18-59
  • smoking / recreational drug use
  • pregnant women / breast feeding
  • contraindication to MRI
  • contraindications to Zaleplon
  • history of cardiovascular pulmonary or cerebral disease (hypertension (diastolic >90 mmHg, systolic > 150 mmHg), unstable cerebrovascular syndromes, prior history of cardiac arrhythmias, unstable angina, chronic obstructive pulmonary disease).
  • Current SSRI antidepressant medication
  • History of sleep disorder or currently taking sedative / stimulant medication

结局指标

主要结局

Cerebral MRI Changes

时间窗: 90 Minutes of Sleep

Change in MRI Signal from Awake Baseline

次要结局

未报告次要终点

研究者

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

David Dubowitz

Associate Professor

University of California, San Diego

研究点 (1)

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