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临床试验/NCT02896491
NCT02896491已完成不适用

Radiofrequency Electromagnetic Fields (RF-EMF) Effects on Brain Activity During Wake and Sleep in Healthy Elderly Males

The Federal Office for Radiation Protection, Germany2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
sleep EEG (power)

研究概览

简要总结

To investigate possible effects of radio frequency electromagnetic fields on EEG activity during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG potentials, auditory evoked potentials) and cognitive performance measures in test of selective attention, divided attention and working memory in healthy elderly males (60 - 80 years).

详细描述

To investigate possible effects of radio frequency electromagnetic fields on EEG activity during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG potentials, auditory evoked potentials) and cognitive performance measures in test of selective attention, divided attention and working memory in healthy elderly males (60 - 80 years).

Subjects will be exposed with signals from mobile communication handheld devices for 7.5 h during the night and for the whole duration of the test session during the day. Exposures will be GSM (900 MHz), TETRA (400 MHz) and sham. Each subject is exposed with each exposure three times in addition to an adaptation/screening night and day to learn the test.

The results have to be discussed in the context of possible health risks resulting from RF-EMF exposure.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • healthy male subjects (age 60 - 80 years)
  • right handedness
  • alpha EEG as resting state EEG
  • non-smokers

排除标准

  • acute illness
  • severe neurological, psychiatric or internal disease
  • CNS active medication
  • sleep disorders
  • drug abuse

结局指标

主要结局

sleep EEG (power)

时间窗: during exposure for 8 hours

次要结局

  • resting state Waking EEG (power)(during exposure 4 hours)

研究者

发起方
The Federal Office for Radiation Protection, Germany
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Heidi Danker-Hopfe, Ph.D.

Head of Competence Center of Sleep Medicine and Sleep Research

Charite University, Berlin, Germany

研究点 (2)

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RF-EMF Effects on the CNS in Elderly Men | 临床试验