Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-02 @ 12:46 PM
Study NCT ID:
NCT05072457
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2021-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Benefit of Assistive Listening Device for Lateralization
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], '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': 'phonakaudiologyresearch@gmail.com', 'phone': '405-548-4335', 'title': 'Lead Investigator', 'organization': 'Hearts for Hearing'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'description': 'All participants underwent testing with both the Roger On Microphone and the Roger Select Microphone during one day testing session. Therefore, all participants are combined for the Adverse Event Reporting.', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental', 'description': 'All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers.\n\nRoger On microphone: Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids\n\nRoger Select microphone: Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lateralization Hearing Ability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers.\n\nRoger On microphone: Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids\n\nRoger Select microphone: Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids'}], 'classes': [{'title': '% Correct using Roger On microphone', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '53.33', 'upperLimit': '100'}]}]}, {'title': '% Correct using Roger Select microphone', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '26.67', 'upperLimit': '73.33'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000'], 'groupDescription': 'MANOVA analysis with independent variable being the intervention condition (type of microphone used) and dependent variable being the performance on lateralization task.\n\nNull hypothesis: There will be no statistically significant difference in lateralization test scores between the Roger On and the Roger Select in the experimental group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of 1 day study', 'description': 'Participants indicate which direction (left, center, or right) target speech sentences are coming from while competing noise is also presented via four corner speakers. A higher number of correct responses indicates better lateralization ability. This will be done with two Roger microphone systems (Roger On and Roger Select)', 'unitOfMeasure': 'percent correct responses', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Spatial Hearing Ability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers.\n\nRoger On microphone: Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids\n\nRoger Select microphone: Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids'}], 'classes': [{'title': '% Correct using Roger On microphone', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '7.78', 'upperLimit': '72.5'}]}]}, {'title': '% Correct using Roger Select microphone', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '73.75'}]}]}], 'analyses': [{'pValue': '>.05', 'groupIds': ['OG000'], 'groupDescription': 'Independent variable: intervention condition (type of microphone used), Dependent variable: performance on spatial hearing task. Null hypothesis: There will be no statistically significant difference in spatial hearing test scores between the Roger On and the Roger Select in the experimental group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of 1 day study', 'description': 'Participants repeat sentences presented from the left speaker, while ignoring overlapping competing sentences presented from the right speaker. A higher percentage of correctly repeated words indicates a better spatial hearing score. This task will be performed using two Roger microphone systems (Roger On and Roger Select)', 'unitOfMeasure': 'percentage of words correctly repeated', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental', 'description': 'All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers.\n\nRoger On microphone: Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids\n\nRoger Select microphone: Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental', 'description': 'All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers.\n\nRoger On microphone: Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids\n\nRoger Select microphone: Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '87'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'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': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Adults with moderate-severe bilateral sensorineural hearing loss'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-26', 'size': 164703, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-24T18:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-17', 'studyFirstSubmitDate': '2021-09-28', 'resultsFirstSubmitDate': '2023-04-24', 'studyFirstSubmitQcDate': '2021-09-28', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-24', 'studyFirstPostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lateralization Hearing Ability', 'timeFrame': 'Day 1 of 1 day study', 'description': 'Participants indicate which direction (left, center, or right) target speech sentences are coming from while competing noise is also presented via four corner speakers. A higher number of correct responses indicates better lateralization ability. This will be done with two Roger microphone systems (Roger On and Roger Select)'}, {'measure': 'Spatial Hearing Ability', 'timeFrame': 'Day 1 of 1 day study', 'description': 'Participants repeat sentences presented from the left speaker, while ignoring overlapping competing sentences presented from the right speaker. A higher percentage of correctly repeated words indicates a better spatial hearing score. This task will be performed using two Roger microphone systems (Roger On and Roger Select)'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hearing Loss, Sensorineural']}, 'descriptionModule': {'briefSummary': 'Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a Phonak Roger microphone and hearing aid with compatible Phonak Roger receiver. Target speech will be presented from multiple directions while competing diffuse background noise is presented simultaneously. Participants will repeat back words and percent correct is calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experienced hearing aid users, age 18 or older\n* Bilateral, symmetric moderate to moderate-severe sensorineural hearing loss\n* Good understanding of the English language\n* Health outer ear as confirmed by otoscopy\n* Informed consent as documented by signature\n\nExclusion Criteria:\n\n* Contraindications to the medical device noted upon otoscopy\n* Known hypersensitivity or allergies to materials of the investigations device or comparator\n* Inability to produce reliable test results\n* Known psychological problems\n* Self reported symptoms of vertigo or dizziness'}, 'identificationModule': {'nctId': 'NCT05072457', 'briefTitle': 'Benefit of Assistive Listening Device for Lateralization', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonova AG'}, 'officialTitle': 'Benefit of Assistive Listening Device for Lateralization and Spatial Hearing', 'orgStudyIdInfo': {'id': 'SRF-387'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers.', 'interventionNames': ['Device: Roger On microphone', 'Device: Roger Select microphone']}], 'interventions': [{'name': 'Roger On microphone', 'type': 'DEVICE', 'description': 'Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids', 'armGroupLabels': ['Experimental']}, {'name': 'Roger Select microphone', 'type': 'DEVICE', 'description': 'Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Hearts for Hearing', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonova AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hearts for Hearing', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}