Radiofrequency Electromagnetic Field (RF-EMF) Effects on Brain Activity During Sleep and Waking in Healthy Elderly Women
EMF60+women
Einfluss Hochfrequenter Elektromagnetischer Felder Auf Gehirnaktivität, Schlaf Und Kognitive Leistungsfähigkeit älterer Frauen
1 other identifier
interventional
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 24, 2016
CompletedFirst Posted
Study publicly available on registry
September 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedFebruary 10, 2021
February 1, 2021
2.8 years
August 24, 2016
February 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sleep assessed by EEG power
during 8 h exposure
Secondary Outcomes (1)
restin g state waking EEG (Power)
during exposure 4 h
Study Arms (3)
GSM 900 MHz
EXPERIMENTALRadiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law
TETRA 385 MHz
EXPERIMENTALRadiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law
Sham Exposure
EXPERIMENTALRadiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law
Interventions
Eligibility Criteria
You may qualify if:
- healthy male subjects (age 60 - 80 years) right handedness alpha EEG as resting state EEG
You may not qualify if:
- acute illness severe neurological, psychiatric or internal disease CNS active medication sleep disorders drug abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Competence Center Sleep Medicine
Berlin, 12203, Germany
Related Publications (1)
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.
PMID: 32014649DERIVED
Study Officials
- STUDY DIRECTOR
Blanka Pophof, Ph.D.
Federal Office of Radiation Protection
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Competence Center of Sleep Medicine
Study Record Dates
First Submitted
August 24, 2016
First Posted
September 20, 2016
Study Start
April 1, 2014
Primary Completion
December 31, 2016
Study Completion
July 31, 2018
Last Updated
February 10, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share