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ISRCTN
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ISRCTN81432775
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ClinicalTrials.gov identifier
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Public title
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The effect of mobile phone use on symptoms and neuroendocrine function in 'normal' and 'hypersensitive' users
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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The study has been approved by the Institute of Psychiatry/South London and Maudsley NHS Trust Ethical Committee (Research)(reference: 131/02)
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Study design
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Double-blind, within participants, randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Sensitivity to radiofrequency fields / electrosensitivity
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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.
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Anticipated start date
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01/09/2003
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Anticipated end date
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30/06/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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60 participants will be recruited for each group
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Interventions
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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.
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Primary outcome measure(s)
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Our primary outcome will consist of self-reported headache severity during exposure, recorded using a 0-100 mm visual analogue scale.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Funded by the UK Mobile Telecommunications and Health Research programme (MTHR)
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Trial website
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Publications
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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
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Contact name
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Prof
Simon
Wessely
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Address
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Mobile Phone Research Unit
New Medical School Building
Bessemer Road
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City/town
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London
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Zip/Postcode
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SE5 9PJ
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Country
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United Kingdom
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Email
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s.wessely@iop.kcl.ac.uk
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Sponsor
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Mobile Telecommunications and Health Research programme (UK)
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Address
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MTHR, c/o HPA Centre for Radiation Protection
Chilton
Didcot
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City/town
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Oxfordshire
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Zip/Postcode
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OX11 0RQ
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Country
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United Kingdom
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Email
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mthr@nrpb.org
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Sponsor website:
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http://www.mthr.org.uk
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Date applied
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21/12/2005
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Last edited
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09/10/2008
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Date ISRCTN assigned
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10/01/2006
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