Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT01663467
Status:
WITHDRAWN
Last Update Posted:
2016-10-25
First Post:
2012-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Internet and Smartphone Application-delivered Tinnitus Retraining Therapy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000096983', 'term': 'Ginkgo Extract'}], 'ancestors': [{'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'there was no participants who were enrolled in this study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-23', 'studyFirstSubmitDate': '2012-08-08', 'studyFirstSubmitQcDate': '2012-08-10', 'lastUpdatePostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tinnitus Handicap Inventory (THI)', 'timeFrame': '6 months', 'description': 'THI will be evaluated 6 months after TRT using smatrphone and web'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tinnitus', 'smartphone', 'Web'], 'conditions': ['Tinnitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prove the efficacy of the internet and smartphone application-delivered tinnitus retraining therapy (TRT).', 'detailedDescription': 'to investigate the effect of TRT with minimized counseling'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic subjective tinnitus\n\nExclusion Criteria:\n\n* THI \\< 18'}, 'identificationModule': {'nctId': 'NCT01663467', 'briefTitle': 'Efficacy of Internet and Smartphone Application-delivered Tinnitus Retraining Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Efficacy of Internet and Smartphone Application-delivered TRT', 'orgStudyIdInfo': {'id': 'SNUH_YHK_TRT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ginkgo biloba only', 'description': 'control group Ginexin-F 80mg tablet will be given twice a day for 6 months.', 'interventionNames': ['Drug: Ginkgo biloba']}, {'type': 'EXPERIMENTAL', 'label': 'Ginkgo biloba + modified TRT', 'description': 'experimental group modified TRT (tinnitus retraining therapy) using smartphone and web based materials will be added with Ginkgo biloba.\n\nGinexin-F 80mg tablet will be given twice a day for 6 months.', 'interventionNames': ['Drug: Ginkgo biloba', 'Behavioral: modified TRT']}], 'interventions': [{'name': 'Ginkgo biloba', 'type': 'DRUG', 'otherNames': ['Ginexin-F'], 'description': 'Ginexin-F 80mg tablet will be given twice a day for 6 months.', 'armGroupLabels': ['Ginkgo biloba + modified TRT', 'Ginkgo biloba only']}, {'name': 'modified TRT', 'type': 'BEHAVIORAL', 'description': 'modified TRT (tinnitus retraining therapy) using smartphone and web based materials will be added with Ginkgo biloba.\n\nGinexin-F 80mg tablet will be given twice a day for 6 months.', 'armGroupLabels': ['Ginkgo biloba + modified TRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'YOUNG HO KIM, MD., PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Soonchunhyang University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Otolaryngology-Head and Neck Surgery, Seoul National University College of Medicine, Seoul National University Boramae Medical Center', 'investigatorFullName': 'YOUNG HO KIM', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}