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

This study has been completed.
Sponsor:
Collaborators:
Aalborg University
Aarhus University Hospital
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00138905
First received: August 29, 2005
Last updated: September 6, 2007
Last verified: September 2007
  Purpose

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


Condition Intervention Phase
Behavior
Cognition Disorders
Device: UMTS mobile basestation radiation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Experimental Study of Mobile Base Station Related Radio-Frequency Electromagnetic Radiation in Healthy Adults and Adolescents

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Trail Making B (time in seconds)

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 80
Study Start Date: February 2005
Study Completion Date: April 2006
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.

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138905

Locations
Denmark
Dept. of Environmental and Occupational Medicine, Institute of Public Health, University of Aarhus, Vennelyst Boulevard 6. Build. 260.
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aalborg University
Aarhus University Hospital
Investigators
Study Director: Jørgen B. Andersen, Prof. Aalborg University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00138905     History of Changes
Other Study ID Numbers: 2064-04-0009, Project ID 0402-
Study First Received: August 29, 2005
Last Updated: September 6, 2007
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Base station, EMF, human exposure study,Well-being,cognitive

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014