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van CCT (UK)

van CCT (UK)

Perception of electromagnetic fields (EMF) - pre-test of an exposure set-up

- candidate number16019
- NTR NumberNTR4394
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-jan-2014
- Secondary IDsNL45809.041.13 METC UMC Utrecht
- Public TitlePerception of electromagnetic fields (EMF) - pre-test of an exposure set-up
- Scientific TitlePerception of electromagnetic fields (EMF) - pre-test of an exposure set-up
- hypothesisThe exposure set-up is able to achieve truly double-blind exposure conditions. The objective is to assess if people can tell if the exposure unit is on or off. The testing of our exposure unit aims at identifying and eliminating any potential unwanted clues as to the exposure conditions.
- Healt Condition(s) or Problem(s) studiedHealthy volunteers
- Inclusion criteriaAdult healthy volunteers (between 18 65 years old) will be included.
- Exclusion criteriaFor the exposure pre-testing the following exclusion criteria apply so as to ensure that they could pick up potential clues as to the exposure conditions: - hearing aids - being deaf or blind or having obvious serious uncorrected hearing or vision problems.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 13-jan-2014
- planned closingdate31-dec-2014
- Target number of participants50
- InterventionsFor each one of five different exposure types (electromagnetic field signals), volunteers will undergo a series of 10 randomized exposure conditions with 5 times sham and 5 times true exposure. Exposure duration will be 30 seconds, with a very short break between exposure sessions. Volunteers will be asked to indicate whether they thought the exposure was on or off.
- Primary outcomeThe primary outcome will be the percentage of correct guesses of the exposure conditions per exposure unit.
- Secondary outcomeWe will inquire information about unwanted clues as to exposure conditions (e.g. clicking sounds by the antenna or amplifier, etc.).
- TimepointsDirectly before and after testing.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Institute for Risk Assessment Sciences (IRAS)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryFor usage in provocation experiments, two custom-made mobile exposure units were developed, which can generate extremely-low frequency magnetic fields and radio-frequency electromagnetic fields. Field types and strengths are as encountered in everyday life (e.g. from a WiFi). The units can produce repeated sham/true exposure conditions in random order selected by a computerized randomization scheme in order to achieve double blinding. In this trial we test whether the units can indeed achieve double-blinded exposure conditions, meaning that there are no unwanted clues from which a person can tell when exposure is on, such as sounds or vibrations. 25 healthy volunteers per unit are exposed to short repeated sham and true exposures and are asked when they thought exposure was on and why they thought so. The primary outcome is the percentage of correct answers.
- Main changes (audit trail)
- RECORD10-jan-2014 - 5-apr-2014

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