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临床试验/NCT01117597
NCT01117597已完成不适用

Experimental Study on Possible Effects of Radiofrequency (RF) Signal Characteristics Used for the TETRA Standard on Cognitive Functions in Healthy Subjects

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Performance in cognitive tests

研究概览

简要总结

The purpose of this study is to analyse a possible effect of radiofrequency (RF) fields used for Terrestrial Trunked Radio (TETRA) of brain activity and cognitive functions in occupationally exposed subjects.

详细描述

Background

Several international studies on the influence of electromagnetic fields from mobile communications on cognitive performance and brain function during waking and sleep were performed during the last years. No health relevant effects were found below the maximum exposure of 2 Watt per kilogram (W/kg), which applies for the use of mobile devices by the public.

In Germany a new digital radio communication network for security authorities and organisations based on the TETRA standard is set up at present. TETRA (Terrestrial Trunked Radio) uses a frequency band around 400 MHz and has been much less investigated than public mobile communications. The results of the German Mobile Telecommunication Research Programme showed a higher temperature increase of the exposed tissue at 400 MHz than at the frequencies used by mobile phones. For occupational groups using mobile TETRA devices (as for example policemen and firemen), a local exposure up to 10 W/kg is permitted. Possible effects of electromagnetic fields of mobile TETRA devices will be investigated in humans to further reduce scientific uncertainties concerning the impact of the digital radio for security authorities.

Objective

In the present study, possible effects of an exposure with TETRA signals (sham, SAR values of 1.5 W/kg and 6 W/kg) on the brain activity of humans are investigated. A volunteer study is performed on healthy young men, preferentially from the group of potential users who will be occupationally exposed.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • healthy male subjects
  • right handed
  • potential TETRA users
  • alpha-EEG
  • non-smokers

排除标准

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

结局指标

主要结局

Performance in cognitive tests

时间窗: acute effect under exposure will be assessed for a period of 3 hours for 9 test sessions (two weeks apart, three sessions for every exposure condition)

次要结局

  • Sleep quality(acute effect under exposure will be assessed for a period of approximately 8 hours for 9 experimental nights (two weeks apart, three nights for every exposure condition))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heidi Danker-Hopfe

Prof. Dr.

Charite University, Berlin, Germany

研究点 (2)

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