BehaviorPhase 4NCT00138905
Experimental Study of Mobile Base Station Related Radio-Frequency Electromagnetic Radiation
A Phase 4 study testing UMTS mobile basestation radiation in people with Behavior and Cognition Disorders, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Cognition Disorders
- What is being tested?
- UMTS mobile basestation radiation
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2005to Apr 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy Subjects
- Age 15-16 or 25-40 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Environmental and Occupational Medicine, Institute of Public Health, University of Aarhus, Vennelyst Boulevard 6. Build. 260.
Aarhus C, 8000
About this study
Official title: 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
Read the 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.
- Conditions
- Behavior, Cognition Disorders
- Being tested
- UMTS mobile basestation radiation
- Keywords
- Base station, EMF, human exposure study,Well-being,cognitive
- Medical subject headings
- Behavior, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UMTS mobile basestation radiationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Trail Making B (time in seconds)
Secondary outcomes (3)
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startFeb 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehaviorStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, Aarhus University Hospital
- Investigators
- Jørgen B. Andersen, Prof., Study director, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138905
- Sponsor's protocol ID
- 2064-04-0009
- Other IDs
- Project ID 0402-
- Status last verified
- Sep 2007
- First submitted
- 29 Aug 2005
- Last updated
- 10 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Study of Mobile Base Station Related Radio-Frequency Electromagnetic Radiation in Healthy Adults and Adolescents
- ClinicalTrials.gov ID
- NCT00138905
- Acronym / sponsor ID
- 2064-04-0009
- Conditions
- Behavior, Cognition Disorders
- Keywords
- Base station, EMF, human exposure study,Well-being,cognitive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aalborg University, Aarhus University Hospital
- Study start
- Feb 2005
- Study completion
- Apr 2006 (actual)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Healthy Subjects
- Age 15-16 or 25-40 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UMTS mobile basestation radiation | Device | – |
Primary outcome
Trail Making B (time in seconds)
3 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jørgen B. Andersen, Prof. study director
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing UMTS mobile basestation radiation in people with Behavior and Cognition Disorders, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trail Making B (time in seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2007.