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

Primary Purpose

Behavior, Cognition Disorders

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
UMTS mobile basestation radiation
Sponsored by
University of Aarhus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Behavior focused on measuring Base station, EMF, human exposure study,Well-being,cognitive

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Outcomes

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)

Full Information

First Posted
August 29, 2005
Last Updated
September 6, 2007
Sponsor
University of Aarhus
Collaborators
Aalborg University, Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00138905
Brief Title
Experimental Study of Mobile Base Station Related Radio-Frequency Electromagnetic Radiation
Official Title
Experimental Study of Mobile Base Station Related Radio-Frequency Electromagnetic Radiation in Healthy Adults and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus
Collaborators
Aalborg University, Aarhus University Hospital

4. Oversight

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior, Cognition Disorders
Keywords
Base station, EMF, human exposure study,Well-being,cognitive

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
UMTS mobile basestation radiation
Primary Outcome Measure Information:
Title
Trail Making B (time in seconds)
Secondary Outcome Measure Information:
Title
Reaction Time (RTI), complex reaction and movement time: time (in seconds);
Title
Rapid Visual Information Processing (RVP), RVP A': score (between 0 and 1);
Title
Paired Associated Learning (PAL), PAL Stages completed: (0, 1, 2, 3, 4, 5, 6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jørgen B. Andersen, Prof.
Organizational Affiliation
Aalborg University
Official's Role
Study Director
Facility Information:
Facility Name
Dept. of Environmental and Occupational Medicine, Institute of Public Health, University of Aarhus, Vennelyst Boulevard 6. Build. 260.
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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

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