Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-31 @ 6:27 AM
Study NCT ID:
NCT01187251
Status:
COMPLETED
Last Update Posted:
2010-08-24
First Post:
2010-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Tinnitus Amongst Teenagers and Young Adults mp3 Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}, {'id': 'D006317', 'term': 'Hearing Loss, Noise-Induced'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'id': 'D034381', 'term': 'Hearing Loss'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-23', 'studyFirstSubmitDate': '2010-08-23', 'studyFirstSubmitQcDate': '2010-08-23', 'lastUpdatePostDateStruct': {'date': '2010-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tinnitus', 'mp3 players', 'noise induced hearing loss', 'high frequencies audiometry', 'acoustic otoemissions'], 'conditions': ['Tinnitus']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the incidence of tinnitus between mp3 users and non-users, aged between 15 and 30 years old. 100 patients will be recruited in Valença secondary schools. High frequency audiometry and otoacoustic emissions will be performed.Tinnitus patients will complete the Tinnitus Handicap Inventory questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'teenagers and young adults (15 to 30 years old)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 15 to 30 years old\n* A-n tympanogram\n\nExclusion Criteria:\n\n* muscular tinnitus\n* vascular tinnitus\n* somatosensorial tinnitus\n* concomitant TMJ disorders\n* external and middle ear diseases\n* professional or recreative exposure to other noise sources other than mp3 players'}, 'identificationModule': {'nctId': 'NCT01187251', 'briefTitle': 'Incidence of Tinnitus Amongst Teenagers and Young Adults mp3 Users', 'organization': {'class': 'OTHER', 'fullName': 'Faculdade de Medicina de Valenca'}, 'orgStudyIdInfo': {'id': 'tinnitus and mp3 players'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 - mp3 users', 'description': 'Subjects who have been using mp3 players for at least 1 hour per day for at least 1 year'}, {'label': 'Group 2 - mp3 non-users', 'description': 'Subjects who does not listen regularly to mp3 music'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27600-000', 'city': 'Valença', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'caculdade de Medicina de Valença', 'geoPoint': {'lat': -22.24556, 'lon': -43.70028}}, {'zip': '27255-650', 'city': 'Volta Redonda', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'OTOSUL,Otorrinolaringologia Sul-Fluminense', 'geoPoint': {'lat': -22.52306, 'lon': -44.10417}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculdade de Medicina de Valenca', 'class': 'OTHER'}}}}