HealthyTETRANCT01117597
Terrestrial Trunked Radio (TETRA) and Cognitive Functions in Healthy Subjects
A study testing low RF exposure level and high RF exposure in people with Healthy, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to analyse a possible effect of radiofrequency (RF) fields used for Terrestrial Trunked Radio (TETRA) of brain activity and cognitive functions in occupationally exposed subjects. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- low RF exposure level and high RF exposure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Sep 2014
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male subjects
- right handed
- potential TETRA users
- alpha-EEG
- non-smokers
Who cannot join
- acute illness
- severe neurological, psychiatric or internal disease
- ZNS-active medication
- sleep disorders
- drug abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site
Competence Sleep Medicine CC15, Charité University Medicine Berlin
Berlin, 14050
About this study
Official title: Experimental Study on Possible Effects of Radiofrequency (RF) Signal Characteristics Used for the TETRA Standard on Cognitive Functions in Healthy Subjects
The purpose of this study is to analyse a possible effect of radiofrequency (RF) fields used for Terrestrial Trunked Radio (TETRA) of brain activity and cognitive functions in occupationally exposed subjects.
Read the detailed description
Background
Several international studies on the influence of electromagnetic fields from mobile communications on cognitive performance and brain function during waking and sleep were performed during the last years. No health relevant effects were found below the maximum exposure of 2 Watt per kilogram (W/kg), which applies for the use of mobile devices by the public.
In Germany a new digital radio communication network for security authorities and organisations based on the TETRA standard is set up at present. TETRA (Terrestrial Trunked Radio) uses a frequency band around 400 MHz and has been much less investigated than public mobile communications. The results of the German Mobile Telecommunication Research Programme showed a higher temperature increase of the exposed tissue at 400 MHz than at the frequencies used by mobile phones. For occupational groups using mobile TETRA devices (as for example policemen and firemen), a local exposure up to 10 W/kg is permitted. Possible effects of electromagnetic fields of mobile TETRA devices will be investigated in humans to further reduce scientific uncertainties concerning the impact of the digital radio for security authorities.
Objective
In the present study, possible effects of an exposure with TETRA signals (sham, SAR values of 1.5 W/kg and 6 W/kg) on the brain activity of humans are investigated. A volunteer study is performed on healthy young men, preferentially from the group of potential users who will be occupationally exposed.
Tests are performed allowing conclusions on reaction speed and accuracy, processing of acoustic and visual information, ability to concentrate, memory and resilience.
In parallel, the waking EEG (electroencephalogram, examination of brain activity) under different conditions (rest, processing of tests) is recorded and evaluated.
Furthermore, the influence of TETRA exposure on sleep quality and sleep EEG, as well as performance and well being on the following day are investigated.
The results will be evaluated in relation to their health relevance for occupationally exposed users.
Volunteers
For study participation, young male subjects professionally engaged with TETRA at the age of 18 - 30 years are recruited, who are preferentially not active in night service, right handed and non-smokers.
- Scientific knowledge In other European countries, security authorities have been using TETRA radio networks for some time. Similar to Germany, other European countries are actually setting up their nationwide networks. Some of these countries have accompanied the introduction of the TETRA standard by scientific research. At the beginning of the present study, the scientists of Charité Berlin performed a literature review on health effects of the digital radio bringing together data from publications and reports on the various national scientific results. Overall there are much less data for TETRA than for mobile communications. The few results published previously do not prove any health effects of TETRA.In one study a slight influence on memory was found, which could be by chance a result of the large amount of tests performed. Therefore this result has to be verified. Literature study (PDF, in German, 398 kB, not barrier-free)
- Exposure setup In this study, volunteers are exposed in the head region to a TETRA signal at SAR values of 1.5 Watt per kilogram and 6 Watt per kilogram. A corresponding exposure setup was constructed and characterised by IMST GmbH (Kamp Lintfort). It is a flat antenna worn on the left side of the head which should simulate as far as possible exposures to a TETRA mobile device. It can be worn comfortably for up to eight hours, even during sleep. The true exposure of the individual brain regions was calculated in detail by Seibersdorf Laboratories GmbH. Description of the exposure setup (PDF, in German, 1,7 MB, not barrier-free)
- Perception of warming
An exposure at SAR values of 6 W/kg causes a temperature increase in the head region of almost 1 ° C when using the exposure setup described above. Since the study is to be performed in a blinded way (neither the volunteer nor the directly involved scientist know the actual exposure situation) it is important to prove if the volunteers are able to perceive this warming. Therefore a pilot study was performed. It could be shown, that the volunteers are not able to recognize the actual temperature increase. Therefore, there is no risk of unblinding (the volunteers are not able to discover the specific exposure situation).
Report of the pilot study (PDF, 1,7 MB, in German, not barrier-free)
- Conditions
- Healthy
- Being tested
- low RF exposure level, sham exposure, high RF exposure
- Keywords
- Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low RF exposure levelRadiation
Exposure with 1.5 W/kg
sham exposureRadiation
intervention with sham RF exposure
high RF exposureRadiation
intervention with high RF exposure
| Study group | Role | What they receive |
|---|---|---|
| low RF exposure level | Active comparator | Intervention with low RF exposure level SAR 1.5 W/kg Receives: Radiation: low RF exposure level |
| sham RF exposure | Sham comparator | Intervention with sham RF exposure Receives: Radiation: sham exposure |
| high RF exposure level | Active comparator | intervention with high RF exposure level SAR 6W/kg Receives: Radiation: high RF exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance in cognitive tests
Measured: acute effect under exposure will be assessed for a period of 3 hours for 9 test sessions (two weeks apart, three sessions for every exposure condition)
Secondary outcomes (1)
Sleep quality
Measured: acute effect under exposure will be assessed for a period of approximately 8 hours for 9 experimental nights (two weeks apart, three nights for every exposure condition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- The Federal Office for Radiation Protection, Germany, Seibersdorf Labor GmbH
- Responsible party
- Principal investigator, Heidi Danker-Hopfe, Charite University, Berlin, Germany
- Investigators
- Blanka Pophof, PhD, Study director, The Federal Office for Radiation ProtectionHeidi Danker-Hopfe, PhD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117597
- Sponsor's protocol ID
- AVD20090991
- Acronym
- TETRA
- Status last verified
- Nov 2014
- First submitted
- 4 May 2010
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Study on Possible Effects of Radiofrequency (RF) Signal Characteristics Used for the TETRA Standard on Cognitive Functions in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01117597
- Acronym / sponsor ID
- TETRA / AVD20090991
- Conditions
- Healthy
- Keywords
- Healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- The Federal Office for Radiation Protection, Germany, Seibersdorf Labor GmbH
- Study start
- Apr 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 5 May 2010 (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 analyse a possible effect of radiofrequency (RF) fields used for Terrestrial Trunked Radio (TETRA) of brain activity and cognitive functions in occupationally exposed subjects.
Detailed description
Background
Several international studies on the influence of electromagnetic fields from mobile communications on cognitive performance and brain function during waking and sleep were performed during the last years. No health relevant effects were found below the maximum exposure of 2 Watt per kilogram (W/kg), which applies for the use of mobile devices by the public.
In Germany a new digital radio communication network for security authorities and organisations based on the TETRA standard is set up at present. TETRA (Terrestrial Trunked Radio) uses a frequency band around 400 MHz and has been much less investigated than public mobile communications. The results of the German Mobile Telecommunication Research Programme showed a higher temperature increase of the exposed tissue at 400 MHz than at the frequencies used by mobile phones. For occupational groups using mobile TETRA devices (as for example policemen and firemen), a local exposure up to 10 W/kg is permitted. Possible effects of electromagnetic fields of mobile TETRA devices will be investigated in humans to further reduce scientific uncertainties concerning the impact of the digital radio for security authorities.
Objective
In the present study, possible effects of an exposure with TETRA signals (sham, SAR values of 1.5 W/kg and 6 W/kg) on the brain activity of humans are investigated. A volunteer study is performed on healthy young men, preferentially from the group of potential users who will be occupationally exposed.
Tests are performed allowing conclusions on reaction speed and accuracy, processing of acoustic and visual information, ability to concentrate, memory and resilience.
In parallel, the waking EEG (electroencephalogram, examination of brain activity) under different conditions (rest, processing of tests) is recorded and evaluated.
Furthermore, the influence of TETRA exposure on sleep quality and sleep EEG, as well as performance and well being on the following day are investigated.
The results will be evaluated in relation to their health relevance for occupationally exposed users.
Volunteers
For study participation, young male subjects professionally engaged with TETRA at the age of 18 - 30 years are recruited, who are preferentially not active in night service, right handed and non-smokers.
- Scientific knowledge In other European countries, security authorities have been using TETRA radio networks for some time. Similar to Germany, other European countries are actually setting up their nationwide networks. Some of these countries have accompanied the introduction of the TETRA standard by scientific research. At the beginning of the present study, the scientists of Charité Berlin performed a literature review on health effects of the digital radio bringing together data from publications and reports on the various national scientific results. Overall there are much less data for TETRA than for mobile communications. The few results published previously do not prove any health effects of TETRA.In one study a slight influence on memory was found, which could be by chance a result of the large amount of tests performed. Therefore this result has to be verified. Literature study (PDF, in German, 398 kB, not barrier-free)
- Exposure setup In this study, volunteers are exposed in the head region to a TETRA signal at SAR values of 1.5 Watt per kilogram and 6 Watt per kilogram. A corresponding exposure setup was constructed and characterised by IMST GmbH (Kamp Lintfort). It is a flat antenna worn on the left side of the head which should simulate as far as possible exposures to a TETRA mobile device. It can be worn comfortably for up to eight hours, even during sleep. The true exposure of the individual brain regions was calculated in detail by Seibersdorf Laboratories GmbH. Description of the exposure setup (PDF, in German, 1,7 MB, not barrier-free)
- Perception of warming
An exposure at SAR values of 6 W/kg causes a temperature increase in the head region of almost 1 ° C when using the exposure setup described above. Since the study is to be performed in a blinded way (neither the volunteer nor the directly involved scientist know the actual exposure situation) it is important to prove if the volunteers are able to perceive this warming. Therefore a pilot study was performed. It could be shown, that the volunteers are not able to recognize the actual temperature increase. Therefore, there is no risk of unblinding (the volunteers are not able to discover the specific exposure situation).
Report of the pilot study (PDF, 1,7 MB, in German, not barrier-free)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low RF exposure level | Active comparator | Radiation: low RF exposure levelIntervention with low RF exposure level SAR 1.5 W/kg |
| sham RF exposure | Sham comparator | Radiation: sham exposureIntervention with sham RF exposure |
| high RF exposure level | Active comparator | Radiation: high RF exposureintervention with high RF exposure level SAR 6W/kg |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy male subjects
- right handed
- potential TETRA users
- alpha-EEG
- non-smokers
Key exclusion criteria (5 listed)
- acute illness
- severe neurological, psychiatric or internal disease
- ZNS-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 |
|---|---|---|
| low RF exposure levelExposure with 1.5 W/kg | Radiation | low RF exposure level |
| sham exposureintervention with sham RF exposure | Radiation | sham RF exposure |
| high RF exposureintervention with high RF exposure | Radiation | high RF exposure level |
Primary outcome
Performance in cognitive tests
Time frame: acute effect under exposure will be assessed for a period of 3 hours for 9 test sessions (two weeks apart, three sessions for every exposure condition)
1 secondary outcome
Sleep quality
Time frame: acute effect under exposure will be assessed for a period of approximately 8 hours for 9 experimental nights (two weeks apart, three nights for every exposure condition)
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 25 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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, PhD study director
The Federal Office for Radiation Protection
Heidi Danker-Hopfe, PhD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low RF exposure level and high RF exposure in people with Healthy, run by Charite University, Berlin, 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 5 inclusion and 5 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 25 Aug 2016. 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. Some participants in this study may receive a placebo. 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?
Performance in cognitive tests (time frame: acute effect under exposure will be assessed for a period of 3 hours for 9 test sessions (two weeks apart, three sessions for every exposure condition)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2016.