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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Mobile Phone Research Unit
New Medical School Building
Bessemer Road
London
SE5 9PJ
United Kingdom
| s.wessely@iop.kcl.ac.uk |
Study information
| Study design | Double-blind, within participants, randomised controlled trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| 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 | 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 study start date | 01/09/2003 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 participants will be recruited for each group |
| 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
- England
- United Kingdom
Study participating centre
Mobile Phone Research Unit
London
SE5 9PJ
United Kingdom
SE5 9PJ
United Kingdom
Sponsor information
Mobile Telecommunications and Health Research programme (UK)
Other
Other
MTHR, c/o HPA Centre for Radiation Protection
Chilton
Didcot
Oxfordshire
OX11 0RQ
United Kingdom
| mthr@nrpb.org | |
| Website | http://www.mthr.org.uk |
Funders
Funder type
Not defined
Funded by the UK Mobile Telecommunications and Health Research programme (MTHR)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
