NCT01117597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 25, 2016

Status Verified

November 1, 2014

Enrollment Period

3.4 years

First QC Date

May 4, 2010

Last Update Submit

August 24, 2016

Conditions

Healthy

Keywords

Healthy subjects

Outcome Measures

Primary Outcomes (1)

  • Performance in cognitive tests

    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

    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)

Study Arms (3)

low RF exposure level

ACTIVE COMPARATOR

Intervention with low RF exposure level SAR 1.5 W/kg

Radiation: low RF exposure level

sham RF exposure

SHAM COMPARATOR

Intervention with sham RF exposure

Radiation: sham exposure

high RF exposure level

ACTIVE COMPARATOR

intervention with high RF exposure level SAR 6W/kg

Radiation: high RF exposure

Interventions

low RF exposure levelRADIATION

Exposure with 1.5 W/kg

low RF exposure level
sham exposureRADIATION

intervention with sham RF exposure

sham RF exposure
high RF exposureRADIATION

intervention with high RF exposure

high RF exposure level

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • acute illness
  • severe neurological, psychiatric or internal disease
  • ZNS-active medication
  • sleep disorders
  • drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Competence Sleep Medicine CC15, Charité University Medicine Berlin

Berlin, 14050, Germany

Location

Study Officials

  • Blanka Pophof, PhD

    The Federal Office for Radiation Protection

    STUDY DIRECTOR

  • Heidi Danker-Hopfe, PhD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

May 4, 2010

First Posted

May 5, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2014

Last Updated

August 25, 2016

Record last verified: 2014-11

Locations

DE(1)