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临床试验/NCT04024020
NCT04024020已完成不适用

Chronic Insomnia and CSF Markers of Dementia

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
CSF Markers Related to Dementia

研究概览

简要总结

The longstanding view has been that insomnia, and other forms of sleep disturbance, emerge as a consequence of dementia and are the result of progressive neuronal damage. However, there is growing evidence that the direction of causation may go both ways, with sleep disturbance potentially increasing vulnerability to dementia. Longitudinal studies have found that sleep disturbance often precedes and increases risk for dementia by several years.The purpose of this study is to examine the relationship between chronic insomnia and dementia biomarkers and orexin levels found in cerebrospinal fluid (CSF). Fifteen adults age 30-50 with chronic insomnia and age- and gender-matched good sleepers will undergo overnight polysomnography and CSF sampling in the morning.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 30-50
  • Men and women
  • To be included in the insomnia group, subjects must meet the following DSM5 Diagnostic Criteria for insomnia disorder: dissatisfaction with sleep quantity or quality (difficulty initiating or maintaining sleep, or waking up too early) despite adequate opportunity for sleep; sleep disturbance causes clinical significant distress or impairment in functioning; present at least 3 times per week for at least 3 months; sleep disturbance is not better explained by a medical or psychiatric condition or based on the effects of a substance

排除标准

  • Diagnosis or evidence of sleep disorders other than insomnia as determined by the screening questionnaires and clinical history
  • Women who have been pregnant or lactating within the past six months
  • Non-fluency in spoken or written English
  • Current or past month shiftwork defined as working during the evening or night shift
  • Current use of medications or OTC products that impact sleep
  • Evidence of neurological abnormalities that could include the risks associated with lumbar puncture (e.g.papilledema, mass lesion, Chiari malformation).

结局指标

主要结局

CSF Markers Related to Dementia

时间窗: one morning

CSF levels of the proteins Abeta40 and Abeta42

次要结局

  • CSF Levels of Orexin(one morning)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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