Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-26 @ 8:36 PM
Study NCT ID:
NCT01132092
Status:
COMPLETED
Last Update Posted:
2010-05-27
First Post:
2010-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Normal Standard of Brainstem Auditory Evoked Potential in Adults Using a New Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'lastUpdateSubmitDate': '2010-05-26', 'studyFirstSubmitDate': '2010-05-26', 'studyFirstSubmitQcDate': '2010-05-26', 'lastUpdatePostDateStruct': {'date': '2010-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Evoked Potentials, Adult, Hearing Loss'], 'conditions': ['Normal Hearing (76 Subjects)', 'Subjects With Hearing Loss (15 Subjects)']}, 'descriptionModule': {'briefSummary': 'There are no differences between the exams made with the new device,that evaluates the hearing, and the device gold standard, that is widely used in clinics and hospitals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults Normal hearing subjects and hearing loss Subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hearing thresholds less than 25 dB at all frequencies of pure tone audiometry, with differences between the ears, by frequency, or less than 10 dB.\n* The group with bilateral sensorineural hearing loss was made up of adults with hearing thresholds changed from 25 to 60 dB HL for the frequencies 2000-8000 Hz for pure tone audiometry.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01132092', 'briefTitle': 'The Normal Standard of Brainstem Auditory Evoked Potential in Adults Using a New Device', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual de Ciências da Saúde de Alagoas'}, 'officialTitle': 'The Normal Standard of Brainstem Auditory Evoked Potential in Adults Using a New Device', 'orgStudyIdInfo': {'id': 'UNCISAL-IS-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal hearing (experimental 1)', 'description': '76 Normal hearing subjects, male and female, adults, , evaluated by new device'}, {'label': 'Normal hearing (experimental 2)', 'description': '15 Normal hearing subjects, male and female, adults, , evaluated by new device'}, {'label': 'Hearing loss (experimental 3)', 'description': '15 hearing loss subjects, male and female, adults, evaluated by new device'}, {'label': 'Gold standard 1', 'description': '15 Normal hearing subjects, male and female, adults, evaluated by gold standard device'}, {'label': 'Gold Standard 2', 'description': '15 hearing loss subjects, male and female, adults, evaluated by gold standard device'}]}, 'contactsLocationsModule': {'locations': [{'zip': '57010-300', 'city': 'Maceió', 'state': 'Alagoas', 'country': 'Brazil', 'facility': 'Universidade Estadual de Ciências da Saúde de Alagoas', 'geoPoint': {'lat': -9.66583, 'lon': -35.73528}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Estadual de Ciências da Saúde de Alagoas', 'class': 'OTHER'}}}}