Condition category
Mental and Behavioural Disorders
Date applied
21/12/2005
Date assigned
10/01/2006
Last edited
09/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.mthr.org.uk

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes