Cognitive PerformancePhase 4NCT00395668
TETRA (Terrestrial Trunked Radio)
A Phase 4 study testing TETRA (at lowest carrier freq, std TDMA pulse at 17,6 Hz). in people with Cognitive Performance and Well-Being, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate if electromagnetic radiation from TETRA handset can influence cognitive function and the well-being of healthy 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 25 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance, Well-Being
- What is being tested?
- TETRA (at lowest carrier freq, std TDMA pulse at 17,6 Hz).
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2006to Apr 2007
- 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 25 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- Age 25-50
- Males
- Right-handers
Who cannot join
- Subjects with current or previous cardiovascular disease
- Subjects with current or previous fractured scull
- Subjects with diseases, which could involve a risk for the subject or possible 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. 1260
Aarhus C, 8000
About this study
Official title: Assessment of Acute Changes in Cognitive Performance Arising From Exposure to TETRA Handset.
The purpose of this study is to investigate if electromagnetic radiation from TETRA handset can influence cognitive function and the well-being of healthy adults. Furthermore, the purpose is to provide any special information about the subjects which can cause the possible reactions.
Read the detailed description
TETRA is the term used to describe the technology known as Terrestrial Trunked Radio. It is the European standard digital mobile radio communication system. TETRA has primarily been developed to enable the deployment of secure, digital PMR (Professional Mobile Radio) services required by the public safety and emergency services (police, fire and paramedics). The TETRA system is specified to work within the VHF and UHF bands (150 MHz to 900 MHz) [Chadwick, 2003], and operates most often at frequencies around 400 MHz. The lower frequency means that TETRA is less vulnerable to interference, which is a vital aspect of communications for the emergency services. The system makes it possible to offer complete coverage for the emergency services. One of the TETRA features is that the signal is transmitted in bursts that repeat. The result is a power modulation of some of the RF signal at a frequency of 17,6 Hz (times pr. second) [NRPB, 2001]. This pulsing has led to concerns about its effect on health. Since this pulsing only occurs for transmission from TETRA handset and not from the base stations, most concerns is related to the health effect on the users of TETRA handset.
The aim is to asses whether exposure to TETRA handset can affect cognitive functions and high level brain functions such as learning and problem solving the volunteers will be tested by comparing performance with and without exposure. Sham exposure (no radiation from the handset) vs. TETRA signal (at the lowest carrier frequency, standard TDMA pulsing at 17,6 Hz and a selection of lengths of exposures at the realistic SAR value).
56 healthy males aged 25-50 year working within public safety and emergency services (police, fire and paramedics), is planned to be used in this study. Subjects must be identified as potential users of the TETRA system.
A climatic chamber at the Department of Environmental and Occupational Medicine, Aarhus University, is modified with absorbing lining to dampen reflections from the walls. The climatic chamber is 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 are no other electromagnetic radiators in the chamber. The study will be double blinded as any noise (acoustic and electric) related to exposure will be the same and the person responsible for exposure and exposure assessment will not be able to see each other. The only investigator knowledgeable about the exposure will have no contact with subjects and staff doing measurement. This double blinding will continue until the basic statistical analyses have been conducted.
- Conditions
- Cognitive Performance, Well-Being
- Being tested
- TETRA (at lowest carrier freq, std TDMA pulse at 17,6 Hz).
- Keywords
- TETRA, EMF, Human exposure study, Symptoms, Well-being, Cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TETRA (at lowest carrier freq, std TDMA pulse at 17,6 Hz).Device
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary analysis is the comparison
of the placebo exposure (no radiation) and the TETRA signal
The primary outcome for this analysis is the Trail Making B (time in seconds).
Secondary outcomes (3)
Reaction Time (RTI), complex reaction and movement time
Digit Span forward and backward
'Headache' and 'concentration difficulties' (VAS-scale)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2006 (estimated)
- Study startNov 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive PerformanceStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, Aarhus University Hospital
- Investigators
- Søren K. Kjærgaard, Ass.Prof.PhD, Principal investigator, Institute of Public Health, University of Aarhus, Vennelyst Boulevard 6, Build. 1260
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395668
- Sponsor's protocol ID
- 2103-05-0005
- Other IDs
- Project nr. 0501- (Dept. ID)
- Status last verified
- Sep 2007
- First submitted
- 2 Nov 2006
- 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
- Assessment of Acute Changes in Cognitive Performance Arising From Exposure to TETRA Handset.
- ClinicalTrials.gov ID
- NCT00395668
- Acronym / sponsor ID
- 2103-05-0005
- Conditions
- Cognitive Performance, Well-Being
- Keywords
- TETRA, EMF, Human exposure study, Symptoms, Well-being, Cognitive function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aalborg University, Aarhus University Hospital
- Study start
- Nov 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 3 Nov 2006 (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 electromagnetic radiation from TETRA handset can influence cognitive function and the well-being of healthy adults. Furthermore, the purpose is to provide any special information about the subjects which can cause the possible reactions.
Detailed description
TETRA is the term used to describe the technology known as Terrestrial Trunked Radio. It is the European standard digital mobile radio communication system. TETRA has primarily been developed to enable the deployment of secure, digital PMR (Professional Mobile Radio) services required by the public safety and emergency services (police, fire and paramedics). The TETRA system is specified to work within the VHF and UHF bands (150 MHz to 900 MHz) [Chadwick, 2003], and operates most often at frequencies around 400 MHz. The lower frequency means that TETRA is less vulnerable to interference, which is a vital aspect of communications for the emergency services. The system makes it possible to offer complete coverage for the emergency services. One of the TETRA features is that the signal is transmitted in bursts that repeat. The result is a power modulation of some of the RF signal at a frequency of 17,6 Hz (times pr. second) [NRPB, 2001]. This pulsing has led to concerns about its effect on health. Since this pulsing only occurs for transmission from TETRA handset and not from the base stations, most concerns is related to the health effect on the users of TETRA handset.
The aim is to asses whether exposure to TETRA handset can affect cognitive functions and high level brain functions such as learning and problem solving the volunteers will be tested by comparing performance with and without exposure. Sham exposure (no radiation from the handset) vs. TETRA signal (at the lowest carrier frequency, standard TDMA pulsing at 17,6 Hz and a selection of lengths of exposures at the realistic SAR value).
56 healthy males aged 25-50 year working within public safety and emergency services (police, fire and paramedics), is planned to be used in this study. Subjects must be identified as potential users of the TETRA system.
A climatic chamber at the Department of Environmental and Occupational Medicine, Aarhus University, is modified with absorbing lining to dampen reflections from the walls. The climatic chamber is 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 are no other electromagnetic radiators in the chamber. The study will be double blinded as any noise (acoustic and electric) related to exposure will be the same and the person responsible for exposure and exposure assessment will not be able to see each other. The only investigator knowledgeable about the exposure will have no contact with subjects and staff doing measurement. This double blinding will continue until the basic statistical analyses have been conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects
- Age 25-50
- Males
- Right-handers
Key exclusion criteria (3 listed)
- Subjects with current or previous cardiovascular disease
- Subjects with current or previous fractured scull
- Subjects with diseases, which could involve a risk for the subject or possible 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 |
|---|---|---|
| TETRA (at lowest carrier freq, std TDMA pulse at 17,6 Hz). | Device | – |
Primary outcome
The primary analysis is the comparison
of the placebo exposure (no radiation) and the TETRA signal
The primary outcome for this analysis is the Trail Making B (time in seconds).
3 secondary outcomes
Reaction Time (RTI), complex reaction and movement time
Digit Span forward and backward
'Headache' and 'concentration difficulties' (VAS-scale)
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.
Related trials for Cognitive Performance
Recruiting
Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
PARKINSON DISEASE (Disorder), Parkinsonism or Parkinson's Disease Nos
Not yet recruiting
Effects of Cognitive Restructuring Intervention on Competitive State Anxiety and Volleyball Skill Performance Among Female Collegiate Volleyball Players in Guangzhou, China
Competitive State Anxiety, Volleyball Skill Performance
Not yet recruiting
Effects of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Cognition, Dual-Task Performance, and Interoceptive Accuracy
Cognition, Healthy Volunteers
Not yet recruitingObservational study
EEG Markers From Polysomnography and Cognitive Performance in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Cognitive Impairment
Not yet recruiting
Back Massage Before a Cognitive Task in Healthy Young Adults
Cognitive Performance in Healthy Adults
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.
Søren K. Kjærgaard, Ass.Prof.PhD principal investigator
Institute of Public Health, University of Aarhus, Vennelyst Boulevard 6, Build. 1260
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 TETRA (at lowest carrier freq, std TDMA pulse at 17,6 Hz). in people with Cognitive Performance and Well-Being, 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 4 inclusion and 3 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?
The primary analysis is the comparison. The study lists 3 primary outcomes in all. 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.