Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-10 @ 2:33 PM
Study NCT ID:
NCT00578058
Status:
COMPLETED
Last Update Posted:
2011-08-03
First Post:
2007-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial Of 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': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-02', 'studyFirstSubmitDate': '2007-12-18', 'studyFirstSubmitQcDate': '2007-12-19', 'lastUpdatePostDateStruct': {'date': '2011-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Iowa Tinnitus Handicap Questionnaire', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Tinnitus measures', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Tinnitus']}, 'descriptionModule': {'briefSummary': 'Millions of Americans suffer from tinnitus. However, there is no widely accepted treatment that has been shown to be effective in controlled investigations. The purpose of this study is to evaluate the effectiveness of Tinnitus Retraining Therapy (TRT). This study will investigate the contributions of counseling, the use of hearing aids and sound generators, and the importance of setting masking noise to a particular level. All groups will receive the same Counseling. In pilot studies we have developed a picture-based counseling protocol. The results of this study will determine if TRT is more effective than masking or counseling alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have experienced tinnitus for at least 4 months.\n* Have the ability to participate in research.\n\nExclusion Criteria:\n\n* Have a treatable otological disorder.\n* Are involved in litigation.\n* Have or are suspected of having a serious psychiatric problem.'}, 'identificationModule': {'nctId': 'NCT00578058', 'briefTitle': 'Randomized Trial Of Tinnitus Retraining Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Randomized Trial Of Tinnitus Retraining Therapy', 'orgStudyIdInfo': {'id': 'R01DC005972', 'link': 'https://reporter.nih.gov/quickSearch/R01DC005972', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01DC005972', 'link': 'https://reporter.nih.gov/quickSearch/R01DC005972', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Counseling plus everyday noise type 1', 'interventionNames': ['Other: Counseling and Sound Therapy']}, {'type': 'OTHER', 'label': '2', 'description': 'Counseling plus static noise type 2', 'interventionNames': ['Other: Counseling and Sound Therapy']}, {'type': 'OTHER', 'label': '3', 'description': 'Counseling plus static noise type 3', 'interventionNames': ['Other: Counseling and Sound Therapy']}, {'type': 'OTHER', 'label': '4', 'description': 'Hearing aid and counseling plus everyday noise type 1', 'interventionNames': ['Other: Counseling and Sound Therapy']}, {'type': 'OTHER', 'label': '5', 'description': 'Hearing aid and counseling plus static noise type 2', 'interventionNames': ['Other: Counseling and Sound Therapy']}, {'type': 'OTHER', 'label': '6', 'description': 'Hearing aid and counseling plus static noise type 3', 'interventionNames': ['Other: Counseling and Sound Therapy']}], 'interventions': [{'name': 'Counseling and Sound Therapy', 'type': 'OTHER', 'description': 'Tinnitus counseling and sound therapy', 'armGroupLabels': ['1', '2', '3', '4', '5', '6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '14214', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University at Buffalo, State University of New York', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '37614', 'city': 'Johnson City', 'state': 'Tennessee', 'country': 'United States', 'facility': 'East Tennessee State University', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}], 'overallOfficials': [{'name': 'Richard S Tyler, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Richard S. Tyler, Ph.D.', 'oldOrganization': 'University of Iowa'}}}}