The aim is to assess if people can perceive if the exposure-unit is on or off.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gezonde vrijwilligers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the percentage of correct guesses of the exposure
conditions. If overall the percentage of correct guesses exceeds 54% then the
exposure set-up needs to get adjusted to get rid of unwanted clues.
Secondary outcome
Clues as to whether the applied exposure conditions are true or sham conditions
reported by study participants (such as clicks, light)
Background summary
Individuals who attribute their health complaints to electromagnetic fields
(EMF) are frequently referred to as *electromagnetic hypersensitive* (EHS). The
ability to sense exposure to EMF, or *electromagnetic sensibility*, has been
described as a likely prerequisite for EHS.
Electromagnetic sensibility may be reported via acute, transient symptoms, or
by just sensing the fields. No scientific evidence corroborates that
electromagnetic sensibility exists, or that short-term exposures to
non-ionizing electromagnetic fields causes any health effects. However, in
severe cases, subjects who suffer from EHS may be severely limited in their
daily activities and wellbeing. Strategies on how EHS affected persons can be
helped are urgently needed. In the near future, we plan to perform an
experimental study where we offer individuals reporting they can sense
electromagnetic fields the possibility to verify this hypothesis with a
personalized testing procedure. Since it is paramount for such a study that
exposure testing can be performed under perfectly double blind conditions,
without any clues as to whether the applied exposure conditions are true or
sham conditions, we plan to first perform a test to check our exposure unit
with a group of at least 20 healthy volunteers for each one of two exposure
units. In the current scientific literature there is no indication that healthy
volunteers are able to feel electromagnetic fields as will be applied here.
Study objective
The aim is to assess if people can perceive if the exposure-unit is on or off.
Study design
We will perform an experimental pre-test in a group of at least 20 healthy
volunteers each to test our two exposure units. Volunteers will be exposed to
five different frequency bands: Three different mobile phone base station
frequencies: GSM900, GSM1800 and UMTS; cordless phone frequency (DECT) and
wireless internet connection frequency (WiFi); as well asa second unit with
extremely-low-frequency magnetic fields (ELF-MF: 50Hz sinus field plus four
different levels of other frequency components) will be applied (10 x 5 = 50
exposure conditions in total).
Per volunteer, the testing procedure of our exposure unit will be performed
during a one-time visit of the study centre at the Institute for Risk
Assessment Sciences, Utrecht University, encompassing: (a) explaining the
experiment (signing informed consent), (b) filling in a short questionnaire
indicating self-rated electromagnetic sensibility and regarding EHS (c)
performing a series of 5 x 10 randomized exposure sessions (35min) and
indicating exposure conditions (on/off) per exposure session (d) filling in a
short questionnaire regarding any clues as to exposure condition and EHS and
indicating self-rated electromagnetic sensibility. Finally, if desired by the
respective volunteer, the percentage of correct guesses of the exposure
conditions will be communicated. Total time needed per volunteer is estimated
to not exceed one hour.
In order to also assess experimenter-blinding (i.e. to achieve
double-blinding), the project assistant performing the experiment will also be
asked to report whether he or she thought the exposure was on or off for at
least 1 of the testing procedures.
Intervention
For each one of the five different exposure types, 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 break of 5 seconds
between exposure sessions. Volunteers will be asked to indicate whether they
thought the exposure was on or off.
Study burden and risks
Participants will have to visit the University Utrecht only once, for a maximum
of one hour. Volunteers will be exposed to very short duration exposures, at
levels as they can be regularly encountered in the everyday environment (in
type and strength) , at levels far below legal threshold levels and where no
evidence exists of adverse effects on health or on well-being. Scientific
literature does not indicate that tehere are any health risks.
An incentive of ยค10,- (gift voucher) for the completed visit and an allowance
for travelling costs will be given to the volunteer.
Yalelaan 2
Utrecht 3584 CM
NL
Yalelaan 2
Utrecht 3584 CM
NL
Listed location countries
Age
Inclusion criteria
- healthy adults
- men and women
- between 18 and 65 years
Exclusion criteria
- adults with hearing aids
- adults being deaf or being blind
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL45809.041.13 |
OMON | NL-OMON22402 |