Terrestrial Trunked Radio (TETRA) and Cognitive Functions in Healthy Subjects
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| First Received Date ICMJE | May 4, 2010 | ||||||||
| Last Updated Date | February 16, 2012 | ||||||||
| Start Date ICMJE | April 2010 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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) ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01117597 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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) ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Terrestrial Trunked Radio (TETRA) and Cognitive Functions in Healthy Subjects | ||||||||
| Official Title ICMJE | Experimental Study on Possible Effects of Radiofrequency (RF) Signal Characteristics Used for the TETRA Standard on Cognitive Functions in Healthy Subjects | ||||||||
| Brief 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. |
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| 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.
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) |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE | Healthy | ||||||||
| Intervention ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | September 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years to 30 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01117597 | ||||||||
| Other Study ID Numbers ICMJE | AVD20090991 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Heidi Danker-Hopfe, Professor PhD, Charité University Medicine Berlin | ||||||||
| Study Sponsor ICMJE | Charite University, Berlin, Germany | ||||||||
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| Information Provided By | Charite University, Berlin, Germany | ||||||||
| Verification Date | December 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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