RF-EMF Effects on the CNS in Elderly Men (EMF60+males)

February 9, 2021 updated by: Heidi Danker-Hopfe, Ph.D., The Federal Office for Radiation Protection, Germany

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12203
        • Competence Center Sleep Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

Radiation: Exposure with non-ionizing electromagnetic fields:

exposure with TETRA (6W/kg)
Radiation: Exposure with non-ionizing electromagnetic fields
In a cross-over design subjects will be exposed to sham (placebo), GSM 900 MHz (2W/kg) and TETRA (6W/kg)
Sham Comparator: Sham exposure
Radiation: Exposure with non-ionizing electromagnetic fields: exposure with 0 W/kg
Radiation: Exposure with non-ionizing electromagnetic fields
In a cross-over design subjects will be exposed to sham (placebo), GSM 900 MHz (2W/kg) and TETRA (6W/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sleep EEG (power)
Time Frame: during exposure for 8 hours
during exposure for 8 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
resting state Waking EEG (power)
Time Frame: during exposure 4 hours
during exposure 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Federal Office for Radiation Protection, Germany

Collaborators

Seibersdorf Labor GmbH

Investigators

  • Study Chair: Blanka Pophof, Ph.D, Federal Office of Radiation Protection

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 12, 2016

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 3616S82430

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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