Experimental Study of Mobile Base Station Related Radio-Frequency Electromagnetic Radiation

September 6, 2007 updated by: University of Aarhus

Experimental Study of Mobile Base Station Related Radio-Frequency Electromagnetic Radiation in Healthy Adults and Adolescents

The purpose of this study, is to investigate if low intensity electromagnetic radiation, can influence the cognitive performances and well being of healthy adolescents and adults. Furthermore, the purpose is to provide any special information about the subjects which can cause the possible reactions. Finally, the investigation will try to clarify if there is anything specific in the radiation signal that causes the effect

Study Overview

Status

Completed

Detailed Description

EMF-exposure has been related to reported symptoms of sleep-disorders, headaches, nervousness, fatigue, and concentration difficulties. This study intends to focus on these symptoms related to the UMTS control signal.

The purpose of this study is to investigate the possible annoyance from very low intensity electromagnetic radiation, as it exists from modern antenna masts supporting mobile communication. Also we try to get a better understanding of the specific parts of the signal leading to symptoms. This investigation tries to clarify the risk for both adults and adolescents, other susceptibility factors, and whether the radiation changes cognitive functions. The above mentioned complaints have been related to psychological distress and somatization, and EMF-related complaints have been reported more by individuals with higher somatization tendency. In the present study, we therefore propose to control for symptoms of somatization and personality traits thought to influence perception and reporting of symptoms.

In this study a signal level of 1 volt/meter (2.6 mW/m2) will be used. This level should correspond to the level, experienced by the general public living rather near a base station antenna. The antenna arrangement will produce an approximation to a plane wave, so that the intensity is constant (within 2 dB) over the volume occupied by the subjects. The subjects are required to sit close to a computer screen and keyboard, which will modify the distribution slightly. The climatic chamber used for the study is modified with absorbing lining to dampen reflections from the walls. The chamber is also modified to make it a screened room to prevent external RF fields, and to some extent low frequency fields, to enter the chamber. Except for cables to the keyboard and screen there will be no other electromagnetic radiators in the chamber. The four different exposure types used, are Sham exposure (no radiation from the antennas), a UMTS signal (typical base station signal, 2140 MHz), a CW (continuous wave) of 2140 MHz. and a Wideband W-CDMA signal, f=2140 MHz, modulated with a random data sequence at a chip rate of 3.8 MHz, corresponding to a pure UMTS modulation signal, without the control signals.

Study Type

Interventional

Enrollment

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aarhus C, Denmark, 8000
        • Dept. of Environmental and Occupational Medicine, Institute of Public Health, University of Aarhus, Vennelyst Boulevard 6. Build. 260.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Subjects
  • Age 15-16 or 25-40 years

Exclusion Criteria:

  • Pregnant
  • Subjects with current or previous cardiovascular disease
  • Subjects with current or previous fractured scull
  • Subjects with chronic lung disease
  • Subjects with diseases, which could involve a risk for the subject or possibly influence the outcome measurements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Trail Making B (time in seconds)

Secondary Outcome Measures

Outcome Measure
Reaction Time (RTI), complex reaction and movement time: time (in seconds);
Rapid Visual Information Processing (RVP), RVP A': score (between 0 and 1);
Paired Associated Learning (PAL), PAL Stages completed: (0, 1, 2, 3, 4, 5, 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jørgen B. Andersen, Prof., Aalborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

September 10, 2007

Last Update Submitted That Met QC Criteria

September 6, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • 2064-04-0009
  • Project ID 0402-

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe