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Terrestrial Trunked Radio (TETRA) and Cognitive Functions in Healthy Subjects

This study is currently recruiting participants.
Verified December 2009 by Charite University, Berlin, Germany
Sponsor:
Collaborators:
The Federal Office for Radiation Protection
Seibersdorf Labor GmbH
IMST GmbH
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01117597
First received: May 4, 2010
Last updated: February 16, 2012
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Radiation: low RF exposure level
Radiation: sham exposure
Radiation: high RF exposure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Experimental Study on Possible Effects of Radiofrequency (RF) Signal Characteristics Used for the TETRA Standard on Cognitive Functions in Healthy Subjects

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: low RF exposure level
Intervention with low RF exposure level SAR 1.5 W/kg
 Radiation: low RF exposure level
Exposure with 1.5 W/kg
Sham Comparator: sham RF exposure
Intervention with sham RF exposure
 Radiation: sham exposure
intervention with sham RF exposure
Active Comparator: high RF exposure level
intervention with high RF exposure level SAR 6W/kg
 Radiation: high RF exposure
intervention with high RF exposure

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male subjects
  • right handed
  • potential TETRA users
  • alpha-EEG
  • non-smokers

Exclusion Criteria:

  • acute illness
  • severe neurological, psychiatric or internal disease
  • ZNS-active medication
  • sleep disorders
  • drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117597

Contacts
Contact: Cornelia Sauter, PhD +493084458634 cornelia.sauter@charite.de
Contact: Anita Peter, MD +493084458630 anita.peter@charite.de

Locations
Germany
Competence Sleep Medicine CC15, Charité University Medicine Berlin Recruiting
Berlin, Germany, 14050
Contact: Cornelia Sauter, PhD     +493084458634     cornelia.sauter@charte.de    
Contact: Anita Peter, MD     +493084458630     anita.peter@charite.de    
Principal Investigator: Heidi Danker-Hopfe, PhD            
Sponsors and Collaborators
Charite University, Berlin, Germany
The Federal Office for Radiation Protection
Seibersdorf Labor GmbH
IMST GmbH
Investigators
Study Director: Blanka Pophof, PhD The Federal Office for Radiation Protection
Principal Investigator: Heidi Danker-Hopfe, PhD Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Heidi Danker-Hopfe, Professor PhD, Charité University Medicine Berlin
ClinicalTrials.gov Identifier: NCT01117597     History of Changes
Other Study ID Numbers: AVD20090991
Study First Received: May 4, 2010
Last Updated: February 16, 2012
Health Authority: Germany: Institutional Review Board

Keywords provided by Charite University, Berlin, Germany:
Healthy subjects

ClinicalTrials.gov processed this record on May 21, 2013