Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-08 @ 1:18 PM
Study NCT ID:
NCT00833950
Status:
COMPLETED
Last Update Posted:
2009-03-03
First Post:
2009-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase Out in Tinnitus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}], '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': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'lastUpdateSubmitDate': '2009-03-02', 'studyFirstSubmitDate': '2009-01-30', 'studyFirstSubmitQcDate': '2009-01-30', 'lastUpdatePostDateStruct': {'date': '2009-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': '3x/week'}], 'secondaryOutcomes': [{'measure': 'Score on Tinnitus Questionnaire', 'timeFrame': 'week 0, week 3, week 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tinnitus', 'Phase Out'], 'conditions': ['Tinnitus']}, 'descriptionModule': {'briefSummary': 'Phase shift treatment is a new tinnitus therapy that aims at sound cancelling via complete or partial residual inhibition. This technique is based on the theory by Choy advocating that the induction of a sound wave with a 180 degree phase shift compared to the sound experienced by the patient could result in sound cancelling, likely by negation of the cortical perception of tinnitus.\n\nThe aim is to determine the efficacy of the Phase Out treatment in pure tone and narrow band noise tinnitus patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consult ENT department UZA with tinnitus\n* pure tone tinnitus or narrow band noise tinnitus\n* unilateral tinnitus, or bilateral tinnitus if both ears pure tone or both ears narrow band noise\n* frequency tinnitus \\> 1kHz\n* cochlear origin tinnitus\n* tinnitus duration 3 months or longer\n* age 18y or more\n* patient being able to cooperate\n* patiënt able to fill in VAS\n* normal MRI pontine angle\n\nExclusion Criteria:\n\n* depression: BDI \\> 21\n* pulsatile tinnitus\n* pregnancy\n* epilepsy'}, 'identificationModule': {'nctId': 'NCT00833950', 'briefTitle': 'Phase Out in Tinnitus Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'Phase Out Treatment for Tinnitus', 'orgStudyIdInfo': {'id': '8/2/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'narrow band noise', 'description': 'Phase out in narrow band noise tinnitus patients', 'interventionNames': ['Device: Phase Out treatment in pure tone tinnitus patients']}], 'interventions': [{'name': 'Phase Out treatment in pure tone tinnitus patients', 'type': 'DEVICE', 'description': 'Phase Out treatment: 30 min 3x/w during 6 weeks', 'armGroupLabels': ['narrow band noise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'Antwerp university Hospital', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof Dr P H Van de Heyning', 'oldOrganization': 'Antwerp University Hospital'}}}}