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临床试验/NCT02685891
NCT02685891进行中(未招募)不适用

Exploring Diurnal Changes in Markers of Cortical Plasticity Using Multimodal Imaging in Healthy Children, Adolescents and Adults

University Children's Hospital, Zurich2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年6月1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)
发起方
入组人数
90
试验地点
2
主要终点
Diurnal changes in brain metabolites

研究概览

简要总结

In this study, the investigator evaluates whether there are age-specific diurnal changes in markers of cortical plasticity in children, adolescents and adults. The question will be investigated by the quantification of brain metabolites and structural brain volumes using magnet resonance imaging (MRI) and electrophysiological markers using sleep encephalography (sleep EEG). In a second step, it will be tested how these markers of cortical plasticity change depending on a modulation of sleep by applying tones during deep sleep.

详细描述

Given that children and adolescents undergo entirely different maturational processes (children show an increase, adolescents a decrease in synapse density) larger diurnal changes in children are expected compared to adolescents concerning brain metabolites and structural markers. These cortical changes in synapse density are thought to be reflected in electrophysiological markers in the sleep EEG (children show a higher slow wave activity, adolescents a reduced slow wave activity). With the modulation of the deep (slow wave) sleep by playing short, low volume tones, the investigators want to test if there is a causal relationship between slow wave sleep and markers of cortical plasticity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
8 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female subjects 8 to 30 years of age,
  • good general health Status
  • right-handedness,
  • Written informed consent after participants' information

排除标准

  • sleep disorders (insomnia, sleep disordered breathing, restless legs syndrome)
  • sleep complaints in general
  • irregular sleep-wake rhythm
  • daytime sleep
  • travelling across a time zone within the last month
  • diseases or lesions of the central nervous system
  • psychiatric diseases
  • learning disability
  • skin allergy or very sensitive skin
  • acute pediatric disease
  • pregnancy
  • drug and medication use and abuse
  • nicotine use
  • high caffeine consumption (>2 servings/day (>160 mg caffeine); including coffee, tea, white and dark chocolate, coca cola, energy drink)
  • Alcohol consumption in children and adolescents under 16 years
  • high alcohol consumption in adults (> 1 standard serving/day (>14 mg Alcohol))
  • high alcohol consumption in adolescents aged 16 years and above (> 3-4 Standard servings per week)

结局指标

主要结局

Diurnal changes in brain metabolites

时间窗: 3 years

concentration of brain metabolites measured by MR spectroscopy change from evening to morning

次要结局

  • electrophysiological markers change in dependance of the diurnal variation of brain metabolites(3 years)
  • structural markers change in dependance of the diurnal variation of brain metabolites(3 years)

研究者

发起方
University Children's Hospital, Zurich
申办方类型
Other
责任方
Sponsor

研究点 (2)

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