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

Overview:

Status: Recruiting
Study State Date: April 2010
Primary Completion Date: Anticipated June 2013
Study Type: Interventional
Study Design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Phase: N/A

Sponsor(s):

Charite University, Berlin, Germany
The Federal Office for Radiation Protection

Information By: Charite University, Berlin, Germany
Trial Identifier: NCT01117597
Official Title: Experimental Study on Possible Effects of Radiofrequency (RF) Signal Characteristics Used for the TETRA Standard on Cognitive Functions in Healthy Subjects

Description: 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.

Eligibility:

Accepts Healthy Volunteers?: Accepts Healthy Volunteers
Enrollment: 30 Anticipated
Minimum Age: 18 Years
Maximum Age: 30 Years
Gender(s): Male
Additional 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

Conditions:
Healthy

Interventions:
Radiation: RF exposure
Radiation: RF exposure
Radiation: RF exposure

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)
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)
Safety Issue: No

Patient Groups:

Assigned Interventions:

low RF exposure level: Experimental

Radiation: RF exposure

sham: Sham Comparator

Radiation: RF exposure

high RF exposure level: Experimental

Radiation: RF exposure

Location & Contacts:

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

Investigators:
Study Director: Blanka Pophof, PhD, The Federal Office for Radiation Protection
Principal Investigator: Heidi Danker-Hopfe, PhD, Charite University, Berlin, Germany

Responsible Party:
Charité University Medicine Berlin (Heidi Danker-Hopfe, Professor PhD)

Study Locations:
+ Show All 1 Study Locations

Germany
Competence Sleep Medicine CC15, Charité University Medicine Berlin (Recruiting)
Berlin, Germany
Contact: Cornelia Sauter, PhD +493084458634 cornelia.sauter@charte.de

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