RF-EMF Effects on the CNS in Elderly Men

Not Applicable

Completed

• Conditions: Non-Ionizing Radiation
• Interventions: Radiation: Exposure with non-ionizing electromagnetic fields

• Registration Number: NCT02896491
• Lead Sponsor: The Federal Office for Radiation Protection, Germany

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Primary Completion: 2018-01-31
• Study Completion: 2019-05-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham exposure	Exposure with non-ionizing electromagnetic fields	Radiation: Exposure with non-ionizing electromagnetic fields: exposure with 0 W/kg
GSM 900 MHz exposure	Exposure with non-ionizing electromagnetic fields	Radiation: Exposure with non-ionizing electromagnetic fields exposure with GSM 900 MHz (2W/kg)
TETRA 400 MHz exposure	Exposure with non-ionizing electromagnetic fields	Radiation: Exposure with non-ionizing electromagnetic fields: exposure with TETRA (6W/kg)

Primary Outcome Measures

Name	Time	Method
sleep EEG (power)	during exposure for 8 hours

Secondary Outcome Measures

Name	Time	Method
resting state Waking EEG (power)	during exposure 4 hours

Trial Locations

Locations (1)

Competence Center Sleep Medicine; 🇩🇪 Berlin, Germany