Contact information
Type
Scientific
Primary contact
Prof Simon Wessely
ORCID ID
Contact details
Mobile Phone Research Unit
New Medical School Building
Bessemer Road
London
SE5 9PJ
United Kingdom
s.wessely@iop.kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Exposure to pulsed 900 MHz Global System for Mobile Communications (GSM) radiofrequency fields will be associated with higher symptom reporting and altered neuroendocrine function in comparison to exposure to unpulsed radiofrequency fields or a 'sham' condition.
Ethics approval
The study has been approved by the Institute of Psychiatry/South London and Maudsley NHS Trust Ethical Committee (Research)(reference: 131/02)
Study design
Double-blind, within participants, randomised controlled trial
Primary study design
Observational
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Condition
Sensitivity to radiofrequency fields / electrosensitivity
Intervention
Each participant will be exposed to each of three conditions: pulsed 900 MHz GSM radiofrequency fields, unpulsed radiofrequency fields of the same mean power, and a sham (placebo) condition. Each of these conditions will last for 50 minutes. The order these conditions will be presented in for each participant will be determined using block randomisation.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Our primary outcome will consist of self-reported headache severity during exposure, recorded using a 0-100 mm visual analogue scale.
Secondary outcome measures
Secondary outcomes will include: self-reported severity for nausea, fatigue, dizziness, skin itching, tingling or stinging, sensations of warmth or burning on skin, and eye pain or dryness.
Neuroendocrine outcomes will include: plasma levels of cortisol, adrenocorticotropic hormone, growth hormone and prolactin.
Secondary outcomes will be recorded during each of the three experimental provocations.
Overall trial start date
01/09/2003
Overall trial end date
30/06/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Two samples will be tested, consisting of 'control' and 'sensitive' participants. To be eligible for the sensitive group, participants must report experiencing often headaches within 20 min of using a GSM mobile phone. Only participants who do not attribute any symptoms to mobile phone signals will be eligible for inclusion in the control group.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60 participants will be recruited for each group
Participant exclusion criteria
Participants will be excluded if: under 18, over 75, pregnant, suffering from a psychotic illness, currently using antidepressants, or if they report severe symptoms at baseline while in the testing room.
Recruitment start date
01/09/2003
Recruitment end date
30/06/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Mobile Phone Research Unit
London
SE5 9PJ
United Kingdom
Sponsor information
Organisation
Mobile Telecommunications and Health Research programme (UK)
Sponsor details
MTHR
c/o HPA Centre for Radiation Protection
Chilton
Didcot
Oxfordshire
OX11 0RQ
United Kingdom
mthr@nrpb.org
Sponsor type
Other
Website
Funders
Funder type
Not defined
Funder name
Funded by the UK Mobile Telecommunications and Health Research programme (MTHR)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16520326
Within participants double blind randomised provocation study: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16520326
Publication citations
-
Results
Rubin GJ, Hahn G, Everitt BS, Cleare AJ, Wessely S, Are some people sensitive to mobile phone signals? Within participants double blind randomised provocation study., BMJ, 2006, 332, 7546, 886-891, doi: 10.1136/bmj.38765.519850.55.
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Within participants double blind randomised provocation study
Rubin GJ, Hahn G, Everitt BS, Cleare AJ, Wessely S, Are some people sensitive to mobile phone signals? Within participants double blind randomised provocation study., BMJ, 2006, 332, 7546, 886-891, doi: 10.1136/bmj.38765.519850.55.