Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-30 @ 7:09 AM
Study NCT ID:
NCT05244603
Status:
COMPLETED
Last Update Posted:
2025-03-26
First Post:
2022-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Application of Ideal Binary Masking to Disordered Speech
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'id': 'D004401', 'term': 'Dysarthria'}], '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'}, {'id': 'D001184', 'term': 'Articulation Disorders'}, {'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarah.leopold@usu.edu', 'phone': '6145708258', 'title': 'Dr. Sarah Yoho Leopold', 'organization': 'Utah State University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years 29 days', 'eventGroups': [{'id': 'EG000', 'title': 'Normal Hearing', 'description': 'Listeners with normal hearing\n\nIdeal binary mask: Speech in noise processed by ideal binary mask to reduce background noise', 'otherNumAtRisk': 422, 'deathsNumAtRisk': 422, 'otherNumAffected': 0, 'seriousNumAtRisk': 422, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hearing Impaired', 'description': 'Listeners with hearing loss\n\nIdeal binary mask: Speech in noise processed by ideal binary mask to reduce background noise', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Correct Speech Intelligibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Hearing', 'description': 'Listeners with normal hearing\n\nIdeal binary mask: Speech in noise processed by ideal binary mask to reduce background noise'}, {'id': 'OG001', 'title': 'Hearing Impaired', 'description': 'Listeners with hearing loss\n\nIdeal binary mask: Speech in noise processed by ideal binary mask to reduce background noise'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '63', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One hour', 'description': "Percent of keywords correctly identified by the participant for the processed speech stimuli, listeners were presented with phrases containing several words and they reported back what they heard. The number of words corrected reported by each listener was counted and converted to a 'percent correct' score.", 'unitOfMeasure': 'percentage of words correctly reported', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Listeners with normal hearing and listeners with hearing loss'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal Hearing', 'description': 'Listeners with normal hearing\n\nIdeal binary mask: Speech in noise processed by ideal binary mask to reduce background noise'}, {'id': 'FG001', 'title': 'Hearing Impaired', 'description': 'Listeners with hearing loss\n\nIdeal binary mask: Speech in noise processed by ideal binary mask to reduce background noise'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '422'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '422'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '435', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal Hearing', 'description': 'Listeners with normal hearing\n\nIdeal binary mask: Speech in noise processed by ideal binary mask to reduce background noise'}, {'id': 'BG001', 'title': 'Hearing Impaired', 'description': 'Listeners with hearing loss\n\nIdeal binary mask: Speech in noise processed by ideal binary mask to reduce background noise'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '410', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '414', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '12', 'groupId': 'BG000'}, {'value': '69', 'spread': '26', 'groupId': 'BG001'}, {'value': '52', 'spread': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Overall represents both groups of listeners, row populations are subgroups'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '391', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '363', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '376', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '422', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '435', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Speech intelligibility +5 dB SNR', 'classes': [{'categories': [{'measurements': [{'value': '40', 'spread': '5', 'groupId': 'BG000'}, {'value': '24', 'spread': '16', 'groupId': 'BG001'}, {'value': '32.5', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of words correct', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Overall represents both groups of listeners, row population represents subgroups'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-03', 'size': 295304, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-03-24T10:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 435}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2022-02-04', 'resultsFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2022-02-14', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-24', 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Correct Speech Intelligibility', 'timeFrame': 'One hour', 'description': "Percent of keywords correctly identified by the participant for the processed speech stimuli, listeners were presented with phrases containing several words and they reported back what they heard. The number of words corrected reported by each listener was counted and converted to a 'percent correct' score."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss, Sensorineural', 'Dysarthria']}, 'referencesModule': {'references': [{'pmid': '36944186', 'type': 'RESULT', 'citation': 'Borrie SA, Yoho SE, Healy EW, Barrett TS. The Application of Time-Frequency Masking To Improve Intelligibility of Dysarthric Speech in Background Noise. J Speech Lang Hear Res. 2023 May 9;66(5):1853-1866. doi: 10.1044/2023_JSLHR-22-00558. Epub 2023 Mar 21.'}]}, 'descriptionModule': {'briefSummary': 'Dysarthria and hearing loss are communication disorders that can substantially reduce intelligibility of speech and the addition of background noise adds a further challenge. This proposal utilizes an established signal processing technique, currently exploited for improved understanding of speech in noise for listeners with hearing loss, to investigate its potential application to overcome speech-in-noise difficulties for listeners understanding dysarthric speech. Successful completion of this project will demonstrate proof-of-concept for the application of this signal processing technique to dysarthric speech in noise, and inform the development of an R01 proposal to perform a large-scale evaluation of the technology, and clinically meaningful implications, in a broad range of disordered speech types and severities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:INCLUSION CRITERIA for All Participants\n\n* Native speakers of American English\n* No history of speech or language impairment\n* No significant prior contact with persons having neurogenic speech disorders\n\nINCLUSION CRITERIA for Participants with Normal Hearing\n\n* 18 to 70 years of age\n* Auditory thresholds of 20 dB HL or better bilaterally at octave frequencies from 250-8000 Hz (if under 55 years of age)\n* Auditory thresholds of 25 dB HL or better bilaterally at octave frequencies from 250-4000 Hz (if over 55 years of age)\n\nINCLUSION CRITERIA for Participants with Sensorineural Hearing Loss\n\n* 18 to 90 years of age\n\nExclusion Criteria:\n\n* EXCLUSION CRITERIA for All Participants\n* Mild or profound hearing loss\n* Conductive or mixed hearing loss\n* Asymmetric hearing loss\n* Obvious concomitant cognitive or mental impairment\n* Unable to achieve upward of 20% words correct'}, 'identificationModule': {'nctId': 'NCT05244603', 'briefTitle': 'Application of Ideal Binary Masking to Disordered Speech', 'organization': {'class': 'OTHER', 'fullName': 'Utah State University'}, 'officialTitle': 'Application of Ideal Binary Masking to Disordered Speech', 'orgStudyIdInfo': {'id': '10710'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal Hearing', 'description': 'Listeners with normal hearing', 'interventionNames': ['Behavioral: Ideal binary mask']}, {'type': 'EXPERIMENTAL', 'label': 'Hearing Impaired', 'description': 'Listeners with hearing loss', 'interventionNames': ['Behavioral: Ideal binary mask']}], 'interventions': [{'name': 'Ideal binary mask', 'type': 'BEHAVIORAL', 'description': 'Speech in noise processed by ideal binary mask to reduce background noise', 'armGroupLabels': ['Hearing Impaired', 'Normal Hearing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43221', 'city': 'Logan', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah State University', 'geoPoint': {'lat': 41.73549, 'lon': -111.83439}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Utah State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Sarah Leopold', 'investigatorAffiliation': 'Utah State University'}}}}