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临床试验/NCT02176785
NCT02176785已完成不适用

The Effect of Pre-Frontal tDCS on Sleep Propensity During an Afternoon Nap: RCT

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Sleep onset latency and sleep architecture

研究概览

简要总结

Transcranial Direct Current Stimulation (tDCS) is a safe, non-invasive brain stimulation technology that has demonstrated the ability to temporarily increase or decrease activity in specific regions of the brain. The researchers are investigating the effect of this technology on sleep propensity by applying two different types of stimulation as well as sham (Placebo) stimulation during three different afternoon naps. The researchers are subsequently hoping to recruit healthy volunteers without medical, or sleep problems who have a regular sleep schedule to participate in the study

详细描述

Recent studies have demonstrated that there are cortical direct current (DC) changes that accompany sleep onset and transitions between sleep states in a stereotyped manner. In these studies it was determined that negative potential shifts occurred prior to and at the transition from wakefulness to sleep and at transitions between Rapid Eye Movement sleep (REM) sleep, and Non-Rapid Eye Movement (NREM) sleep. In a subset of experiments it was demonstrated that the same DC potential shifts occur during the transition from wake to sleep in an afternoon nap. The recorded DC potential shifts occurred predominantly in the pre-frontal cortex (F3, F4), with spread into central areas. No current literature exists that explores whether tDCS could be used to modulate cortical activity prior to sleep, resulting in either increased or decreased sleep propensity.

The application of focal, non-invasive brain stimulation has already led to novel and effective treatments for neuropsychiatric disease with minimal side effects (Most well studied in depression and repetitive Transcranial Magnetic Stimulation or, rTMS). Should the application of tDCS modulate sleep propensity it would represent a novel study paradigm with the potential to lead to a completely novel treatment for sleep disturbance. With this small pilot study, we propose taking the first step in exploring the utility of tDCS in modulating sleep propensity. We propose to recruit 15 healthy non-treatment seeking participants from the community and expose them to three total nap conditions in a randomized counter balanced fashion, with 10 minutes of either, Anodal, Cathodal, or Sham tDCS stimulation occurring prior to each nap opportunity.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-65
  • capable of coming in for an initial intake screen, and then again for 2 hours on consecutive Monday, Wednesday, and Friday afternoons

排除标准

  • Presence of Neurologic, psychiatric, or sleep disorder.
  • Current use of medications affecting the central nervous system.
  • Daily consumption of alcohol, or consequences of alcohol use (DUI, occupational, or social dysfunction ect.).
  • Tobacco use.
  • Consumption of more than the equivalent of 300mg of caffeine daily.
  • Habitual sleep duration of less than 6 ½ hours, greater than 8 ½ hours, a difference between weeknight, and weekend sleep of greater than 3 hours, or typical sleep timing more than 3 hours outside of the window of 10pm-6am.
  • Score of greater than 5 on the Pittsburgh Sleep Quality Index (PSQ-I), or 10 on the Epworth Sleepiness scale (ESS).
  • BMI greater than 30, or Heavy snoring.
  • Pregnancy.

研究组 & 干预措施

Sham tDCS

Sham Comparator

tDCS will be applied, but then turned off after 30 seconds.

干预措施: transcranial Direct Current Stimulation (tDCS) (Device)

Anodal tDCS 2mA 10 Minutes

Experimental

Anodal tDCS will be applied bi-frontally for 10 minutes at 2mA

干预措施: transcranial Direct Current Stimulation (tDCS) (Device)

Cathodal tDCS 2mA 10 Minutes

Experimental

Cathodal tDCS will be applied Bi-Frontally for 10 minutes at 2mA

干预措施: transcranial Direct Current Stimulation (tDCS) (Device)

结局指标

主要结局

Sleep onset latency and sleep architecture

时间窗: 30 Minutes

Sleep onset latency and sleep architecture will be assessed using polysomnography during a 30 minute nap opportunity.

次要结局

  • Sleep quality(30 Minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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