RF-EMF Effects on the CNS in Elderly Men

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Non-Ionizing Radiation

Intervention / Treatment
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* Radiation: Exposure with non-ionizing electromagnetic fields


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy male subjects (age 60 - 80 years) right handedness alpha EEG as resting state EEG non-smokers Exclusion Criteria: acute illness severe neurological, psychiatric or internal disease CNS active medication sleep disorders drug abuse

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSM 900 MHz exposure<br>Radiation: Exposure with non-ionizing electromagnetic fields exposure with GSM 900 MHz (2W/kg) | Radiation: Exposure with non-ionizing electromagnetic fields<br>* In a cross-over design subjects will be exposed to sham (placebo), GSM 900 MHz (2W/kg) and TETRA (6W/kg)<br>|
| Experimental: TETRA 400 MHz exposure<br>Radiation: Exposure with non-ionizing electromagnetic fields: exposure with TETRA (6W/kg) | Radiation: Exposure with non-ionizing electromagnetic fields<br>* In a cross-over design subjects will be exposed to sham (placebo), GSM 900 MHz (2W/kg) and TETRA (6W/kg)<br>|
| Sham Comparator: Sham exposure<br>Radiation: Exposure with non-ionizing electromagnetic fields: exposure with 0 W/kg | Radiation: Exposure with non-ionizing electromagnetic fields<br>* In a cross-over design subjects will be exposed to sham (placebo), GSM 900 MHz (2W/kg) and TETRA (6W/kg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep EEG (power) |  | during exposure for 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resting state Waking EEG (power) |  | during exposure 4 hours |