- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01872806
Electrophysiological Reactivity Due to Mobile Phone Radiation
April 9, 2015 updated by: Maastricht University Medical Center
Radiation Meter Controlled Electrophysiological Reactivity (EEG and ECG) Due to Mobile Phone Radiation.
The main objective of this study is to investigate whether radiofrequency electromagnetic radiation, induced by a dialing mobile phone placed on the body, causes a change in electrophysiology.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to investigate whether placement of a 3G dialing mobile phone causes direct changes in EEG activity compared to the placement of a sham phone.
Furthermore, it is investigated whether placement of the mobile phone on the ear or the heart results in different outcomes.
The subjects are measured twice: on one of the two days the mobile phone is attached to the ear, the other day to the chest.
In this single-blind, cross-over design, assessments in the sham phone conditions are conducted directly preceding and following the mobile phone exposure.
During each assessment, EEG activity and radiofrequency radiation are recorded jointly.
Delta, theta, alpha, slowbeta, fastbeta, and gamma activity are computed.
The association between radiation exposure and the EEG is tested using multilevel random regression analyses with radiation as predictor of main interest.
Study Type
Interventional
Enrollment (Actual)
93
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6226 NB
- Mondriaan, locatie Vijverdal, Maastricht University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- female aged between 18 - 30 years
Exclusion Criteria:
- cardiac or brain disorder
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Mobile phone radiation
Dialing mobile phone placed against the ear/chest for a duration of 15 minutes, before and after 15 minutes sham phone will be placed against the ear/chest.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in EEG and ECG
Time Frame: during mobile phone exposure (immediately)
|
during mobile phone exposure (immediately)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jim van Os, Maastricht University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
May 30, 2013
First Submitted That Met QC Criteria
June 5, 2013
First Posted (Estimate)
June 7, 2013
Study Record Updates
Last Update Posted (Estimate)
April 10, 2015
Last Update Submitted That Met QC Criteria
April 9, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- METC azM/UM NL44004.068.13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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