Experimental Study on Possible Effects of Radiofrequency (RF) Signal Characteristics Used for the TETRA Standard on Cognitive Functions in Healthy Subjects
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
- 是
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
Heidi Danker-Hopfe
Prof. Dr.
Charite University, Berlin, Germany
