Radiofrequency Electromagnetic Field (RF-EMF) Effects on Brain Activity During Sleep and Waking in Healthy Elderly Women

Not Applicable

Completed

• Conditions: Nervous System Effects
• Interventions: Radiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law

• Registration Number: NCT02906228
• Lead Sponsor: The Federal Office for Radiation Protection, Germany

Brief Summary

The purpose of this study is 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 females (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 females (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

Study Timeline

• Study Start: 2014-04-01
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-20
• Primary Completion: 2016-12-31
• Study Completion: 2018-07-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

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

Inclusion Criteria

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

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
GSM 900 MHz	Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law	Radiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law
Sham Exposure	Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law	Radiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law
TETRA 385 MHz	Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law	Radiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law

Primary Outcome Measures

Name	Time	Method
sleep assessed by EEG power	during 8 h exposure

Secondary Outcome Measures

Name	Time	Method
restin g state waking EEG (Power)	during exposure 4 h

Trial Locations

Locations (1)

Competence Center Sleep Medicine; 🇩🇪 Berlin, Germany