Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-26 @ 4:44 PM
Study NCT ID:
NCT00730834
Status:
UNKNOWN
Last Update Posted:
2009-08-25
First Post:
2008-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and Hyperacusis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}, {'id': 'D012001', 'term': 'Hyperacusis'}], '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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-08-24', 'studyFirstSubmitDate': '2008-08-05', 'studyFirstSubmitQcDate': '2008-08-07', 'lastUpdatePostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre and post treatment scores on Tinnitus reaction questionnaire', 'timeFrame': '6, 12, 24, 36 months'}], 'secondaryOutcomes': [{'measure': 'Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale,', 'timeFrame': '6, 12, 24, 36 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tinnitus', 'ringing in the ears', 'buzzing', 'static', 'hyperacusis', 'loudness discomfort', 'Clinically', 'significant', 'discomfort'], 'conditions': ['Tinnitus', 'Hyperacusis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.neuromonics.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Neuromonics TInnitus Treatment CALM study is a multi site study of 100 adult subjects with clinically significant disturbing tinnitus to evaluate outcome measures using the FDA cleared Neuromonics treatment after 6, 12, 24 and 36 months. Patients must be meet certain inclusion criteria and they are also required to pay for the all costs of the treatment. Subjects will be provided a modest participation fee at 6, 12, 24 and 36 months upon completion of patient questionnaires (subjects must have access to a computer and internet in order to complete on line questionnaires).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age,\n* TRQ of at least 17 or above,\n* Able to pay for the treatment,\n* Not using any other treatment for tinnitus,\n* Access to computer and internet,\n* Compliant patient\n\nExclusion Criteria:\n\n* Hearing PTA \\> 50 dB, score on HADS of greater than 11 on the anxiety and depression scale,\n* Not willing to follow the protocol'}, 'identificationModule': {'nctId': 'NCT00730834', 'acronym': 'CALM', 'briefTitle': 'Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and Hyperacusis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neuromonics, Inc.'}, 'officialTitle': 'Phase 4 Study of Use of a Customized Acoustic Stimulus to Reduce the Disturbing Symptoms of Tinnitus and Hyperacusis', 'orgStudyIdInfo': {'id': 'CALM Study'}, 'secondaryIdInfos': [{'id': '20071022'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Oasis', 'type': 'DEVICE', 'otherNames': ['Neuromonics Oasis Tinnitus Treatment'], 'description': 'Digital sound player that provides customized acoustic stimulus based on subjects hearing thresholds'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Silverstein Ear Institute', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neuromonics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jack Wazen, MD', 'oldOrganization': 'Silverstein ear institute'}}}}