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Completed

NCT Number: NCT02896491

RF-EMF Effects on the CNS in Elderly Men

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).

Completed

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Key information

Conditions

Non-Ionizing Radiation

Age range

60 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Competence Center Sleep Medicine

Berlin, 12203, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure with non-ionizing electromagnetic fields

Radiation

In a cross-over design subjects will be exposed to sham (placebo), GSM 900 MHz (2W/kg) and TETRA (6W/kg)

Primary outcomes

  1. sleep EEG (power)

    Time frame: during exposure for 8 hours

Secondary outcomes

  1. resting state Waking EEG (power)

    Time frame: during exposure 4 hours

Sponsors and collaborators

Lead sponsor

The Federal Office for Radiation Protection, Germany

Other Gov

Collaborators

  • Seibersdorf Labor GmbH

Registry information

Official study title

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

Acronym: EMF60+males

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 12, 2016
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.