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

Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138905
• Other study ID #: 2064-04-0009
• Secondary ID: Project ID 0402-
• Status: Completed
• Phase: Phase 4
• First received: August 29, 2005
• Last updated: September 6, 2007
• Start date: February 2005
• Est. completion date: April 2006

Study information

• Verified date: September 2007
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Behavior
• Cognition Disorders

Intervention

Device:
• UMTS mobile basestation radiation

Locations

Country	Name	City	State
Denmark	Dept. of Environmental and Occupational Medicine, Institute of Public Health, University of Aarhus, Vennelyst Boulevard 6. Build. 260.	Aarhus C

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg University, Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trail Making B (time in seconds)
Secondary	Reaction Time (RTI), complex reaction and movement time: time (in seconds);
Secondary	Rapid Visual Information Processing (RVP), RVP A': score (between 0 and 1);
Secondary	Paired Associated Learning (PAL), PAL Stages completed: (0, 1, 2, 3, 4, 5, 6)