Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT05292534
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2022-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'id': 'D014012', 'term': 'Tinnitus'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ieda.ishida@sonova.com', 'phone': '6472847562', 'title': 'Dr. Ieda Ishida', 'organization': 'Sonova'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '10 months (Between Nov 2022 until September 2023).', 'description': 'Safety population included all participants in this study, who experienced at least one intervention mode.', 'eventGroups': [{'id': 'EG000', 'title': 'Amplification-only', 'description': 'Hearing aid will be fit to prescribed participant hearing loss.\n\nhearing aid amplification: Hearing aid will be fit to prescribed participant hearing loss.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 2, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Amplification With Added Sound', 'description': 'Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated on the hearing aid.\n\nhearing aid amplification with an added sound: Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'No Intervention', 'description': 'Participants will return to their original unaided state.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 2, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Acquired COVID', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ear infection after swimming', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Body ache after general incidents happening during the trial period', 'notes': 'Events were: body ache after moving furniture, body ache after falling in the bathroom at night, mouth discomfort after being stuck open at the dentist during a procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tinnitus Functional Index Evaluation (TFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Amplification-only', 'description': 'Hearing aid will be fit to prescribed participant hearing loss.\n\nhearing aid amplification: Hearing aid will be fit to prescribed participant hearing loss.'}, {'id': 'OG001', 'title': 'Amplification With Added Sound', 'description': 'Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated on the hearing aid.\n\nhearing aid amplification with an added sound: Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated.'}, {'id': 'OG002', 'title': 'No Intervention', 'description': 'Participants will return to their original unaided state.'}], 'classes': [{'title': 'Group 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.6', 'spread': '20', 'groupId': 'OG000'}, {'value': '32', 'spread': '21.9', 'groupId': 'OG001'}, {'value': '44.8', 'spread': '22.2', 'groupId': 'OG002'}]}]}, {'title': 'Group 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.2', 'spread': '19.0', 'groupId': 'OG000'}, {'value': '34.4', 'spread': '19.7', 'groupId': 'OG001'}, {'value': '40.4', 'spread': '16.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'TFI collected before intervention to serve as a baseline. TFI change from baseline will be assessed after each study condition, which will last 4 weeks/each.', 'description': "Tinnitus Functional Index (TFI) questionnaire results, ranging from 0 to 100, with higher numbers indicating more severe (worse) Tinnitus interference in the person's quality of life.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Repeated measures. Participants served as their own control.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amplification-only, Then Amplification With an Added Sound, Then Intervention Withdrawal', 'description': '3 study conditions (4 weeks each):\n\n1. Hearing aid amplification-only,\n2. Hearing aid amplification with an added sound,\n3. intervention withdrawal.\n\nHearing aid was fit to prescribed participant hearing loss for 4 weeks during the 1st intervention period.\n\nThen the participants wore the same study hearing aids for another 4 weeks with an added sound to the amplification setting.\n\nThen the participants returned the hearing devices to the investigator and were re-assessed 4 weeks after intervention withdrawal.'}, {'id': 'FG001', 'title': 'Amplification With Added Sound, Then Amplification-only, Then Intervention Withdrawal', 'description': '3 study conditions (4 weeks each):\n\n1. Hearing aid amplification with an added sound,\n2. Hearing aid amplification-only,\n3. intervention withdrawal.\n\nHearing aid was fit to prescribed participant hearing loss and an added sound activated on the hearing aid and worn for 4 weeks during the 1st intervention period.\n\nThen the participants wore the same study hearing aids for another 4 weeks without the added sound to the amplification setting.\n\nThen the participants returned the hearing devices to the investigator and were re-assessed 4 weeks after intervention withdrawal.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'First participant seen on Jun3 2022', 'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '38 participants signed the consent form and met study criteria', 'preAssignmentDetails': '38 participants were randomly assigned into one of two groups. Out of the 38 participants, 8 dropped out during the study. There were 2 study groups in this cross-over study, and final numbers were 15 participants in each group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cross Over Design, 2 Groups of Participants', 'description': 'First Group: started with amplification-only as a 1st intervention, and switched to amplification+noiser Second Group: started with amplification+noiser as a 1st intervention, and switched to amplification-only'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Group 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62.2', 'spread': '9.5', 'groupId': 'BG000'}]}]}, {'title': 'Group 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60.6', 'spread': '9.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Table above present the mean age (and standard deviation) of each separate group of 15 participants.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Group 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Group 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '30 participants divided into 2 groups of 15 participants/each.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'TFI', 'classes': [{'title': 'Group 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '50', 'spread': '16.1', 'groupId': 'BG000'}]}]}, {'title': 'Group 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '36.2', 'spread': '19.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'points', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '15 participants in each of the 2 groups, totaling 30 participants in the study.'}], 'populationDescription': 'Group 1 and Group 2 had 15 participants/each.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-05', 'size': 134306, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-18T15:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2022-03-09', 'resultsFirstSubmitDate': '2024-04-24', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-01', 'studyFirstPostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tinnitus Functional Index Evaluation (TFI)', 'timeFrame': 'TFI collected before intervention to serve as a baseline. TFI change from baseline will be assessed after each study condition, which will last 4 weeks/each.', 'description': "Tinnitus Functional Index (TFI) questionnaire results, ranging from 0 to 100, with higher numbers indicating more severe (worse) Tinnitus interference in the person's quality of life."}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hearing Loss, Sensorineural', 'Tinnitus']}, 'referencesModule': {'references': [{'pmid': '22156949', 'type': 'BACKGROUND', 'citation': 'Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0.'}, {'pmid': '26074306', 'type': 'BACKGROUND', 'citation': 'Henry JA, Griest S, Thielman E, McMillan G, Kaelin C, Carlson KF. Tinnitus Functional Index: Development, validation, outcomes research, and clinical application. Hear Res. 2016 Apr;334:58-64. doi: 10.1016/j.heares.2015.06.004. Epub 2015 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'Participants with hearing loss and Tinnitus will wear hearing aids with amplification-only or with an added sound, and have their tinnitus level evaluated before and after intervention.', 'detailedDescription': '2 groups of adults with hearing loss and chronic bothersome tinnitus and no experience with amplification will participate in a cross over intervention study with 2 conditions of 4 weeks each: 1. fit with hearing aid (HA) amplification-only, and 2. fit with HA amplification with an added sound, returning to their original unaided condition after undergoing the intervention phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hearing loss\n* candidate for hearing aid amplification\n* Bothersome chronic tinnitus (3 months+)\n\nExclusion Criteria:\n\n* age less than 18 years\n* normal hearing\n* tinnitus presence for less than 3 months\n* tinnitus not bothersome enough to warrant intervention\n* non hearing aid candidates'}, 'identificationModule': {'nctId': 'NCT05292534', 'briefTitle': 'Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonova AG'}, 'officialTitle': 'Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.', 'orgStudyIdInfo': {'id': 'SRF-481'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amplification-only', 'description': 'Hearing aid will be fit to prescribed participant hearing loss.', 'interventionNames': ['Device: hearing aid amplification']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amplification with added sound', 'description': 'Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated on the hearing aid.', 'interventionNames': ['Device: hearing aid amplification with an added sound']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'Participants will return to their original unaided state.'}], 'interventions': [{'name': 'hearing aid amplification', 'type': 'DEVICE', 'description': 'Hearing aid will be fit to prescribed participant hearing loss.', 'armGroupLabels': ['Amplification-only']}, {'name': 'hearing aid amplification with an added sound', 'type': 'DEVICE', 'description': 'Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated.', 'armGroupLabels': ['Amplification with added sound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'The State University of New York at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Wei Sun, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of New York at Buffalo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonova AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'State University of New York at Buffalo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}