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临床试验/NCT02741505
NCT02741505撤回不适用

Open Masking, Micro Motionlogger Actigraph, 3T Siemens MRI, Sleep Deprivation, Nocturnal PSG

NYU Langone Health1 个研究点 分布在 1 个国家开始时间: 2019年6月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Measure of Interstitial Space Volume during sleep using MRI imaging

研究概览

简要总结

The primary purpose of this study is to explore the underlying mechanisms that link sleep to Alzheimer's disease (AD), with special focus on the clearance of metabolites in the extracellular space of the brain during sleep. Subjects will wear an actigraph for 1 week to determine regular daytime activity and sleep patterns. Subjects will then undergo partial sleep deprivation followed by 4 hours of in-lab nocturnal polysomnography (NPSG). Participants will be be asked to stay awake and active all day after the partial sleep deprivation with a new actigraphy secured by a hospital band to assure participants remain awake. They will seep inside an MRI machine for 90 minutes on the following night during their usual bedtime (established by 1 week actigraphy study.) Morphologic imaging, flow imaging and diffusion kurtosis imaging (DKI) will be performed on a 3T Siemens scanner.

研究设计

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

入排标准

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

入选标准

  • Age range 21-30
  • Capable of giving informed consent

排除标准

  • Diagnosis of any brain disease or brain damage including significant trauma, hydrocephalus, seizures, mental retardation or other serious neurological disorders (e.g. Parkinson's disease or other movement disorders). Persons with silent cortical infarcts will be excluded. White matter lesions will not be exclusions.
  • History of major psychiatric illness (e.g., schizophrenia, bipolar or life long history of major depression)
  • Conditions that alter normal sleep patterns: irregular sleep-wake rhythms (based on one week at home monitoring with actigraphy), moderate to severe periodic limb movement while you sleep (PLMS) or Obstructive Sleep Apnea (OSA).
  • History of claustrophobia.
  • Significant history of alcoholism or drug abuse.
  • Inability to avoid the use of alcohol or caffeine during the 48h before the MRI.
  • Current pregnancy or intent to become pregnant during the period of study.
  • Any electronic or ferromagnetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging.
  • Any medications adversely affecting cognition, blood pressure, glucose metabolism, or sleep will result in exclusion.

结局指标

主要结局

Measure of Interstitial Space Volume during sleep using MRI imaging

时间窗: 6 Months

Data will be acquired using imaging sequences that comply with federal limits regarding radiofrequency energy deposition and gradient slew rates.

次要结局

  • Changes in Cerebral Spinal Fluid volume measured by increases in the power of slow wave activity (SWA)(6 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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