We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01117597
First Posted: May 5, 2010
Last Update Posted: August 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Federal Office for Radiation Protection, Germany
Seibersdorf Labor GmbH
Information provided by (Responsible Party):
Heidi Danker-Hopfe, Charite University, Berlin, Germany
  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: Quadruple (Participant, Care Provider, 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 Heidi Danker-Hopfe, 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) ]

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) ]

Enrollment: 32
Study Start Date: April 2010
Study Completion Date: September 2014
Primary Completion Date: September 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117597


Locations
Germany
Competence Sleep Medicine CC15, Charité University Medicine Berlin
Berlin, Germany, 14050
Sponsors and Collaborators
Charite University, Berlin, Germany
The Federal Office for Radiation Protection, Germany
Seibersdorf Labor 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

Responsible Party: Heidi Danker-Hopfe, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01117597     History of Changes
Other Study ID Numbers: AVD20090991
First Submitted: May 4, 2010
First Posted: May 5, 2010
Last Update Posted: August 25, 2016
Last Verified: November 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Heidi Danker-Hopfe, Charite University, Berlin, Germany:
Healthy subjects