The effect of mobile phone use on symptoms and neuroendocrine function in 'normal' and 'hypersensitive' users

ISRCTN	ISRCTN81432775
DOI	https://doi.org/10.1186/ISRCTN81432775
Protocol serial number	N/A
Sponsor	Mobile Telecommunications and Health Research programme (UK)
Funder	Funded by the UK Mobile Telecommunications and Health Research programme (MTHR)

Submission date: 21/12/2005
Registration date: 10/01/2006
Last edited: 09/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Simon Wessely
Scientific

Mobile Phone Research Unit
New Medical School Building
Bessemer Road
London
SE5 9PJ
United Kingdom

Email	s.wessely@iop.kcl.ac.uk

Study information

Primary study design	Observational
Study design	Double-blind, within participants, randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	The study has been approved by the Institute of Psychiatry/South London and Maudsley NHS Trust Ethical Committee (Research)(reference: 131/02)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Our primary outcome will consist of self-reported headache severity during exposure, recorded using a 0-100 mm visual analogue scale.
Key secondary outcome measure(s)	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.
Completion date	30/06/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	120
Key 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.
Key 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.
Date of first enrolment	01/09/2003
Date of final enrolment	30/06/2005

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Mobile Phone Research Unit

London
SE5 9PJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	06/03/2006		Yes	No
Other publications	Within participants double blind randomised provocation study:	15/04/2006		Yes	No