Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-01 @ 9:40 PM
Study NCT ID:
NCT05893992
Status:
COMPLETED
Last Update Posted:
2025-08-17
First Post:
2023-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
fNIRS, Listening Effort, and Motivation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], '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': 'D006310', 'term': 'Hearing Aids'}, {'id': 'D001314', 'term': 'Auscultation'}], 'ancestors': [{'id': 'D000076251', 'term': 'Wearable Electronic Devices'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D012682', 'term': 'Sensory Aids'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jonathan.vaisberg@sonova.com', 'phone': '9057456785', 'title': 'Dr. Jonathan Vaisberg', 'organization': 'Sonova'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Session 1, 2, 3 and 4; assessed for up to 2 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Hearing Loss', 'description': 'All participants will have hearing loss and be assigned to all two interventions. The interventions consist of calm-situation listening and noise management feature.\n\nHearing aids with noise management features for listening in noise: Device for hearing loss compensation with digital noise management features\n\nHearing aid for listening in quiet environments: Device for hearing loss compensation for listening in quiet environments', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Oxygenation Using Functional Near Infrared Spectroscopy (fNIRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Hearing Loss', 'description': 'Participants with hearing loss who are candidates for hearing aids'}], 'classes': [{'title': 'Hearing aid with noise management', 'categories': [{'measurements': [{'value': '-14.85', 'spread': '4.65', 'groupId': 'OG000'}]}]}, {'title': 'Hearing aids for quiet listening', 'categories': [{'measurements': [{'value': '4.15', 'spread': '4.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Session 1, 2, 3 and 4; assessed for up to 2 hours', 'description': 'Infrared light scattered from the prefrontal cortex, which is indicative of concentration of oxygenated blood in that region. fNIRS in the prefrontal cortex is intended to index both motivation and listening effort.', 'unitOfMeasure': 'Oxygenation (uMol)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Listening Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Hearing Loss', 'description': 'Participants with hearing loss who are candidates for hearing aids'}], 'classes': [{'title': 'Hearing aids with noise management', 'categories': [{'measurements': [{'value': '75.8', 'spread': '15.2', 'groupId': 'OG000'}]}]}, {'title': 'Hearing aids for quiet listening', 'categories': [{'measurements': [{'value': '62.3', 'spread': '19.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Session 1, 2, 3 and 4; assessed for up to 2 hours', 'description': 'Speech understanding in noise percent correct scores', 'unitOfMeasure': 'Percentage of words repeated correctly', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Listening Effort Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Hearing Loss', 'description': 'Participants with hearing loss who are candidates for hearing aids'}], 'classes': [{'title': 'Hearing aids with noise management', 'categories': [{'measurements': [{'value': '3.08', 'spread': '0.960', 'groupId': 'OG000'}]}]}, {'title': 'Hearing aids for quiet listening', 'categories': [{'measurements': [{'value': '4.08', 'spread': '0.892', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Session 1, 2, 3 and 4; assessed for up to 2 hours', 'description': 'Participants rate how much listening effort was required in order to make out a sentence from 1-7, where lower scores mean less effort required.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Digital Noise Management, Then Quiet Listening', 'description': 'Participants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation with digital noise management features, followed by the device for hearing loss compensation for listening in quiet environments.'}, {'id': 'FG001', 'title': 'Quiet Listening, Then Digital Noise Management', 'description': 'Participants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation for listening in quiet environments, followed by the device for hearing loss compensation with digital noise management features.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hearing Loss', 'description': 'All participants will have hearing loss and be assigned to all two interventions. The interventions consist of calm-situation listening and noise management feature.\n\nHearing aids with noise management features for listening in noise: Device for hearing loss compensation with digital noise management features\n\nHearing aid for listening in quiet environments: Device for hearing loss compensation for listening in quiet environments'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '69', 'spread': '7.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', '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': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-05', 'size': 200560, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-05T12:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A single cohort of participants will receive and be assessed in all treatment/intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2023-05-30', 'resultsFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2023-05-30', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-28', 'studyFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygenation Using Functional Near Infrared Spectroscopy (fNIRS)', 'timeFrame': 'Session 1, 2, 3 and 4; assessed for up to 2 hours', 'description': 'Infrared light scattered from the prefrontal cortex, which is indicative of concentration of oxygenated blood in that region. fNIRS in the prefrontal cortex is intended to index both motivation and listening effort.'}], 'secondaryOutcomes': [{'measure': 'Listening Accuracy', 'timeFrame': 'Session 1, 2, 3 and 4; assessed for up to 2 hours', 'description': 'Speech understanding in noise percent correct scores'}, {'measure': 'Subjective Listening Effort Rating', 'timeFrame': 'Session 1, 2, 3 and 4; assessed for up to 2 hours', 'description': 'Participants rate how much listening effort was required in order to make out a sentence from 1-7, where lower scores mean less effort required.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'The purpose of the current study is to measure oxygenation in the PFC using fNIRS in a sample of older adults with hearing loss. Participants will be instructed to listen to sentences in noise at a challenging signal-to-noise-ratio, and to repeat the word that they heard and rate how much subjective listening effort was required in order to make out the words. fNIRS will be measured throughout. Participants will complete the task using a hearing aid program intended for listening in quiet, and a hearing aid program with new advanced noise management features.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18-99) years\n* Binaural, symmetrical, sensorineural N2 (mild) to N5 (moderate-severe) hearing loss\n* Fluent in English\n\nExclusion Criteria:\n\n* Minors (17 years or less)\n* Not able to tolerate wearing of hearing aids\n* Vulnerable populations'}, 'identificationModule': {'nctId': 'NCT05893992', 'briefTitle': 'fNIRS, Listening Effort, and Motivation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonova AG'}, 'officialTitle': 'Impacts of Hearing Aid Use on Listening Effort and Motivation Using fNIRS', 'orgStudyIdInfo': {'id': 'SRF-15557'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital noise management, then quiet listening', 'description': 'Participants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation with digital noise management features, followed by the device for hearing loss compensation for listening in quiet environments.', 'interventionNames': ['Device: Hearing aids with noise management features for listening in noise', 'Device: Hearing aid for listening in quiet environments']}, {'type': 'EXPERIMENTAL', 'label': 'Quiet listening, then digital noise management', 'description': 'Participants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation for listening in quiet environments, followed by the device for hearing loss compensation with digital noise management features.', 'interventionNames': ['Device: Hearing aids with noise management features for listening in noise', 'Device: Hearing aid for listening in quiet environments']}], 'interventions': [{'name': 'Hearing aids with noise management features for listening in noise', 'type': 'DEVICE', 'description': 'Device for hearing loss compensation with digital noise management features', 'armGroupLabels': ['Digital noise management, then quiet listening', 'Quiet listening, then digital noise management']}, {'name': 'Hearing aid for listening in quiet environments', 'type': 'DEVICE', 'description': 'Device for hearing loss compensation for listening in quiet environments', 'armGroupLabels': ['Digital noise management, then quiet listening', 'Quiet listening, then digital noise management']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L5L1J3', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sonova Innovation Centre Toronto', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}], 'overallOfficials': [{'name': 'Jinyu Qian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sonova AG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual participant data with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonova AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Toronto Metropolitan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}