Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:40 AM
Study NCT ID:
NCT01872806
Status:
COMPLETED
Last Update Posted:
2015-04-10
First Post:
2013-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrophysiological Reactivity Due to Mobile Phone Radiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-09', 'studyFirstSubmitDate': '2013-05-30', 'studyFirstSubmitQcDate': '2013-06-05', 'lastUpdatePostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in EEG and ECG', 'timeFrame': 'during mobile phone exposure (immediately)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female aged between 18 - 30 years\n\nExclusion Criteria:\n\n* cardiac or brain disorder\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01872806', 'briefTitle': 'Electrophysiological Reactivity Due to Mobile Phone Radiation', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Radiation Meter Controlled Electrophysiological Reactivity (EEG and ECG) Due to Mobile Phone Radiation.', 'orgStudyIdInfo': {'id': 'METC azM/UM NL44004.068.13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Mobile phone radiation', 'description': '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.', 'interventionNames': ['Radiation: a dialing smartphone will be placed on the chest and the ear']}], 'interventions': [{'name': 'a dialing smartphone will be placed on the chest and the ear', 'type': 'RADIATION', 'armGroupLabels': ['Experimental: Mobile phone radiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6226 NB', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Mondriaan, locatie Vijverdal, Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Jim van Os', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}