Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 4:15 PM
Study NCT ID:
NCT01857661
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2013-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-06-19', 'releaseDate': '2014-05-20'}, {'resetDate': '2014-07-19', 'releaseDate': '2014-06-24'}], 'estimatedResultsFirstSubmitDate': '2014-05-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006310', 'term': 'Hearing Aids'}], 'ancestors': [{'id': 'D000076251', 'term': 'Wearable Electronic Devices'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D012682', 'term': 'Sensory Aids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-25', 'studyFirstSubmitDate': '2013-05-15', 'studyFirstSubmitQcDate': '2013-05-17', 'lastUpdatePostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'THI', 'timeFrame': '3 months', 'description': 'tinnitus handicap inventory'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tinnitus', 'hearing loss', 'hearing devices'], 'conditions': ['Tinnitus', 'Hearing Loss']}, 'referencesModule': {'references': [{'pmid': '25073131', 'type': 'DERIVED', 'citation': 'dos Santos GM, Bento RF, de Medeiros IR, Oiticcica J, da Silva EC, Penteado S. The influence of sound generator associated with conventional amplification for tinnitus control: randomized blind clinical trial. Trends Hear. 2014 Jul 23;18:2331216514542657. doi: 10.1177/2331216514542657.'}]}, 'descriptionModule': {'briefSummary': 'The University of Sao Paulo Department of Otorhinolaryngology developed prototypes for a digital new hearing aid with an integrated sound generator. These prototypes assist both hearing rehabilitation (about 10% of the population) and tinnitus sufferers (about 17% of the population).\n\nCurrently, the Brazilian Public Heath Care does not have any such hearing aids. So, the development of devices for the hearing rehabilitation as well as the treatment of tinnitus represents an advance in the implementation of Public Policies in Brazil.\n\nThe aim of this study is to compare the efficacy of the hearing aid with an integrated sound generator and amplification alone for tinnitus control in patients with tinnitus associated hearing loss.', 'detailedDescription': "This study, in the form of a blind randomized clinical trial, was approved by CAPPesq under protocol number: 0163/10.\n\n49 adults with tinnitus and sensorineural hearing loss were randomly assigned into 2 groups. Both groups received counseling about tinnitus. One group received hearing aids with only amplification and the other group received hearing aids with an integrated sound generator. After the fitting process, both groups were told to use the hearing devices 8 hours per day. The outcome measures as the tinnitus handicap inventory and psychoacoustics measurements were conducted by a blind audiologist that didn't know each group each patient belonged to."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild to moderate sensorineural hearing loss\n* tinnitus (THI \\> 20)\n* first user\n\nExclusion Criteria:\n\n* profound hearing loss\n* conductive hearing loss\n* THI \\< 20'}, 'identificationModule': {'nctId': 'NCT01857661', 'briefTitle': 'The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2011/03001-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'control', 'description': 'hearing aid without an integrated sound generator', 'interventionNames': ['Device: hearing aids with only amplification']}, {'type': 'EXPERIMENTAL', 'label': 'sound generator', 'description': 'hearing aid with an integrated sound generator', 'interventionNames': ['Device: sound generator']}], 'interventions': [{'name': 'sound generator', 'type': 'DEVICE', 'description': 'hearing aid with an integrated sound generator', 'armGroupLabels': ['sound generator']}, {'name': 'hearing aids with only amplification', 'type': 'DEVICE', 'armGroupLabels': ['control']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Gisele Munhoes dos Santos', 'investigatorAffiliation': 'University of Sao Paulo'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-05-20', 'type': 'RELEASE'}, {'date': '2014-06-19', 'type': 'RESET'}, {'date': '2014-06-24', 'type': 'RELEASE'}, {'date': '2014-07-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Gisele Munhoes dos Santos, PhD, University of Sao Paulo'}}}}