Nervous System EffectsEMF60+womenNCT02906228
Radiofrequency Electromagnetic Field (RF-EMF) Effects on Brain Activity During Sleep and Waking in Healthy Elderly Women
A study testing Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law in people with Nervous System Effects, run by The Federal Office for Radiation Protection, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nervous System Effects
- What is being tested?
- Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2014to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male subjects (age 60 - 80 years) right handedness alpha EEG as resting state EEG
Who cannot join
- acute illness severe neurological, psychiatric or internal disease CNS active medication sleep disorders drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Einfluss Hochfrequenter Elektromagnetischer Felder Auf Gehirnaktivität, Schlaf Und Kognitive Leistungsfähigkeit älterer Frauen
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).
Read the 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 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
- Conditions
- Nervous System Effects
- Being tested
- Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law
- Keywords
- non-ionizing radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German lawRadiation
| Study group | Role | What they receive |
|---|---|---|
| GSM 900 MHz | Experimental | Radiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law Receives: Radiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law |
| TETRA 385 MHz | Experimental | Radiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law Receives: Radiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law |
| Sham Exposure | Experimental | Radiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law Receives: Radiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep assessed by EEG power
Measured: during 8 h exposure
Secondary outcomes (1)
restin g state waking EEG (Power)
Measured: during exposure 4 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start1 Apr 2014
- Primary completion31 Dec 2016
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nervous System EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Federal Office for Radiation Protection, Germany
- Sponsor type
- Other government
- Collaborators
- Seibersdorf Labor GmbH
- Responsible party
- Principal investigator, Heidi Danker-Hopfe, Ph.D., The Federal Office for Radiation Protection, Germany
- Investigators
- Blanka Pophof, Ph.D., Study director, Federal Office of Radiation Protection
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906228
- Sponsor's protocol ID
- 3614S30012
- Acronym
- EMF60+women
- Status last verified
- Feb 2021
- First submitted
- 24 Aug 2016
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32014649
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Einfluss Hochfrequenter Elektromagnetischer Felder Auf Gehirnaktivität, Schlaf Und Kognitive Leistungsfähigkeit älterer Frauen
- ClinicalTrials.gov ID
- NCT02906228
- Acronym / sponsor ID
- EMF60+women / 3614S30012
- Conditions
- Nervous System Effects
- Keywords
- non-ionizing radiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Federal Office for Radiation Protection, GermanyOther government
- Collaborators
- Seibersdorf Labor GmbH
- Study start
- 1 Apr 2014
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GSM 900 MHz | Experimental | Radiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German lawRadiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law |
| TETRA 385 MHz | Experimental | Radiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German lawRadiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law |
| Sham Exposure | Experimental | Radiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German lawRadiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy male subjects (age 60 - 80 years) right handedness alpha EEG as resting state EEG
Key exclusion criteria (1 listed)
- acute illness severe neurological, psychiatric or internal disease CNS active medication sleep disorders drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law | Radiation | GSM 900 MHz, Sham Exposure, TETRA 385 MHz |
Primary outcome
sleep assessed by EEG power
Time frame: during 8 h exposure
1 secondary outcome
restin g state waking EEG (Power)
Time frame: during exposure 4 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 32014649Danker-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blanka Pophof, Ph.D. study director
Federal Office of Radiation Protection
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law in people with Nervous System Effects, run by The Federal Office for Radiation Protection, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep assessed by EEG power (time frame: during 8 h exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02906228, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.