RF-EMF Effects on the CNS in Elderly Men

NCT ID: NCT02896491

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2019-05-31

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.

Conditions

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Non-Ionizing Radiation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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GSM 900 MHz exposure

Radiation: Exposure with non-ionizing electromagnetic fields exposure with GSM 900 MHz (2W/kg)

Group Type EXPERIMENTAL

Exposure with non-ionizing electromagnetic fields

Intervention Type RADIATION

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

TETRA 400 MHz exposure

Radiation: Exposure with non-ionizing electromagnetic fields:

exposure with TETRA (6W/kg)

Group Type EXPERIMENTAL

Exposure with non-ionizing electromagnetic fields

Intervention Type RADIATION

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

Sham exposure

Radiation: Exposure with non-ionizing electromagnetic fields: exposure with 0 W/kg

Group Type SHAM_COMPARATOR

Exposure with non-ionizing electromagnetic fields

Intervention Type RADIATION

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

Interventions

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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)

Intervention Type RADIATION

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Federal Office for Radiation Protection, Germany

OTHER_GOV

Sponsor Role lead

Seibersdorf Labor GmbH

INDUSTRY

Sponsor Role collaborator

Responsible Party

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Heidi Danker-Hopfe, Ph.D.

Head of Competence Center of Sleep Medicine and Sleep Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Blanka Pophof, Ph.D

Role: STUDY_CHAIR

Federal Office of Radiation Protection

Locations

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Competence Center Sleep Medicine

Berlin, , Germany

Site Status

Countries

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Germany

References

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Eggert T, Dorn H, Sauter C, Schmid G, Danker-Hopfe H. RF-EMF exposure effects on sleep - Age doesn't matter in men! Environ Res. 2020 Dec;191:110173. doi: 10.1016/j.envres.2020.110173. Epub 2020 Sep 12.

Reference Type DERIVED
PMID: 32931791 (View on PubMed)

Danker-Hopfe H, Dorn H, Sauter C, Schmid G, Eggert T. An experimental study on effects of radiofrequency electromagnetic fields on sleep in healthy elderly males and females: Gender matters! Environ Res. 2020 Apr;183:109181. doi: 10.1016/j.envres.2020.109181. Epub 2020 Jan 24.

Reference Type DERIVED
PMID: 32014649 (View on PubMed)

Other Identifiers

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3616S82430

Identifier Type: -

Identifier Source: org_study_id

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