- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00138905
Experimental Study of Mobile Base Station Related Radio-Frequency Electromagnetic Radiation
Experimental Study of Mobile Base Station Related Radio-Frequency Electromagnetic Radiation in Healthy Adults and Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Aarhus C, Denmark, 8000
- Dept. of Environmental and Occupational Medicine, Institute of Public Health, University of Aarhus, Vennelyst Boulevard 6. Build. 260.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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Trail Making B (time in seconds)
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Secondary Outcome Measures
Outcome Measure |
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Reaction Time (RTI), complex reaction and movement time: time (in seconds);
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Rapid Visual Information Processing (RVP), RVP A': score (between 0 and 1);
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Paired Associated Learning (PAL), PAL Stages completed: (0, 1, 2, 3, 4, 5, 6)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jørgen B. Andersen, Prof., Aalborg University
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2064-04-0009
- Project ID 0402-
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