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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02906228
Other study ID # 3614S30012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2014
Est. completion date July 31, 2018

Study information

Verified date February 2021
Source The Federal Office for Radiation Protection, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 31, 2018
Est. primary completion date December 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 60 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Radiation:
Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law


Locations

Country Name City State
Germany Competence Center Sleep Medicine Berlin

Sponsors (2)

Lead Sponsor Collaborator
The Federal Office for Radiation Protection, Germany Seibersdorf Labor GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary sleep assessed by EEG power during 8 h exposure
Secondary restin g state waking EEG (Power) during exposure 4 h