Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-26 @ 2:12 PM
Study NCT ID:
NCT04521166
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2020-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hearing Aid Processing and Working Memory in Realistic Spatial Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}}}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006310', 'term': 'Hearing Aids'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'varsha8904@gmail.com', 'phone': '847-467-0897', 'title': 'Varsha Rallapalli', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Listeners were tested on the same day as the hearing aid fitting and were not provided with time to acclimate to the different settings. Experience with the different hearing aid settings could affect the role of working memory in speech understanding with hearing aids.'}}, 'adverseEventsModule': {'timeFrame': 'No adverse events to report because all-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.', 'description': 'All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Hearing Aid Setting', 'description': 'Hearing aid features presented in this arm include omnidirectional microphone settings, directional microphone settings, fast-acting compression, and slow-acting compression.\n\nHearing aid: Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Speech Intelligibility (Percent Correct Scores)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}, {'units': 'Data Points', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Setting 1', 'description': 'Hearing aid features presented in this arm include omnidirectional microphone settings and fast-acting compression'}, {'id': 'OG001', 'title': 'Setting 2', 'description': 'Hearing aid features presented in this arm include omnidirectional microphone settings and slow-acting compression'}, {'id': 'OG002', 'title': 'Setting 3', 'description': 'Hearing aid features presented in this arm include directional microphone settings and fast-acting compression'}, {'id': 'OG003', 'title': 'Setting 4', 'description': 'Hearing aid features presented in this arm include directional microphone settings and slow-acting compression'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000', 'lowerLimit': '0.52', 'upperLimit': '0.57'}, {'value': '0.59', 'groupId': 'OG001', 'lowerLimit': '0.56', 'upperLimit': '0.62'}, {'value': '0.70', 'groupId': 'OG002', 'lowerLimit': '0.67', 'upperLimit': '0.73'}, {'value': '0.80', 'groupId': 'OG003', 'lowerLimit': '0.78', 'upperLimit': '0.82'}]}]}], 'analyses': [{'pValue': '0.5291', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00990', 'ciLowerLimit': '-0.04075', 'ciUpperLimit': '0.02095', 'pValueComment': 'The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.01572', 'estimateComment': 'Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 1 is significantly different from the slope for Setting 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A linear mixed model was used to assess whether there was a difference between Settings 1 and 2.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1329', 'ciLowerLimit': '0.09880', 'ciUpperLimit': '0.1671', 'pValueComment': 'The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.01740', 'estimateComment': 'Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 3 is significantly different from the slope for Setting 2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A linear mixed model was used to assess whether there was a difference between Setting 2 and Setting 3.'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2016', 'ciLowerLimit': '0.1660', 'ciUpperLimit': '0.2371', 'pValueComment': 'The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.01812', 'estimateComment': 'Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 4 is significantly different from the slope for Setting', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A linear mixed model was used to assess whether there was a difference between Setting 2 and Setting 4.'}, {'pValue': '0.242', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.002', 'pValueComment': 'The a priori threshold for statistical significance was 0.05.', 'groupDescription': 'A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)'}, {'pValue': '0.242', 'groupIds': ['OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.002', 'pValueComment': 'The a priori threshold for statistical significance was 0.05.', 'groupDescription': 'A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)'}, {'pValue': '0.242', 'groupIds': ['OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.002', 'pValueComment': 'The a priori threshold for statistical significance was 0.05.', 'groupDescription': 'A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).'}, {'pValue': '0.242', 'groupIds': ['OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.002', 'pValueComment': 'The a priori threshold for statistical significance was 0.05.', 'groupDescription': 'A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).'}], 'paramType': 'MEAN', 'timeFrame': '~20 mins for each intervention over the course of 1-2 days', 'description': 'Listeners will listen to and repeat recorded low-context sentences mixed with noise from different spatial locations. Speech intelligibility will be measured immediately following hearing aid fitting. Scoring is determined by percentage of words repeated correctly. Scores range from 0-100% (higher score indicates better performance). This task may take up to 1-2 visits (\\~ 2 hours each) for different combinations of hearing aid features. The device will only be worn in the laboratory for the duration of the experimental task and will be retrieved by the investigator at the end of each visit.', 'unitOfMeasure': 'percentage of words correct', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Data Points', 'denomUnitsSelected': 'Data Points', 'populationDescription': 'A total of 42 participants were tested for the study. The study design was a full factorial design where each participant completed the outcome measures with all 4 settings in sub-studies 1 \\& 2. In Sub-study 3, the outcome measures were completed with Settings 1 \\& 3 only. Due to an error in assigning settings, 1 participant each did not listen with settings 1 \\& 3 in sub-study 1; 1 participant did not listen with Setting 3 in sub-study 3.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hearing Aid Setting: Single Arm', 'description': 'All participants listened to hearing aid features presented in this arm include omnidirectional microphone settings, directional microphone settings, slow-acting compression, and fast-acting compression\n\nHearing aid: Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.'}], 'periods': [{'title': 'Sub-study 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Sub-study 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participation in Sub-study 2 and Sub-study 3 was optional for the participants from Sub-study 1. Additionally, participants were allowed to participate in any of the Sub-studies independent from other Sub-studies. From Sub-study 1 to Sub-study 2, 7 participants continued, 14 dropped out, 16 were added.', 'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Sub-study 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participation in Sub-study 3 was optional for the participants from Sub-study 1 and Sub-study 2. Additionally, participants were allowed to participate in any of the Sub-studies independent from other Sub-studies. From Sub-study 2 to Sub-study 3, 9 participants continued, 14 dropped out, 8 were added. Among the participants added newly in Sub-study 3, there were 3 participants previously completed Sub-study 1 (but not Sub-study 2).\n\nTotal of 5 participants completed all 3 Sub-studies.', 'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from the local community in the Chicago area'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hearing Aid Setting', 'description': 'Hearing aid features presented in this arm include omnidirectional microphone settings, directional microphone settings, fast-acting compression, and slow-acting compression\n\nHearing aid: Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.76', 'spread': '7.32', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Decibel Hearing Level', 'classes': [{'categories': [{'measurements': [{'value': '38.38', 'spread': '9.67', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Decibel Hearing Level', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Working Memory Capacity: Percentage of words recalled correctly', 'classes': [{'categories': [{'measurements': [{'value': '44.16', 'spread': '11.35', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Participants within a Sub-study received all the hearing aid settings. The order of the settings was randomized for each individual participant at the point of testing. Participants were not assigned to a particular order. Participants were allowed to participate in one to three Sub-studies and participation in all Sub-studies was not required.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-25', 'size': 387048, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-26T01:02', 'hasProtocol': True}, {'date': '2024-06-25', 'size': 91799, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-26T01:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The participant will be blinded to the hearing aid features being adjusted. The order of presentation of the hearing aid features will be randomized across participants, using a Latin-Square design. The outcomes assessor(s) (who score speech intelligibility) will also be blinded to the conditions.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2020-08-17', 'resultsFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2020-08-19', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-11', 'studyFirstPostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speech Intelligibility (Percent Correct Scores)', 'timeFrame': '~20 mins for each intervention over the course of 1-2 days', 'description': 'Listeners will listen to and repeat recorded low-context sentences mixed with noise from different spatial locations. Speech intelligibility will be measured immediately following hearing aid fitting. Scoring is determined by percentage of words repeated correctly. Scores range from 0-100% (higher score indicates better performance). This task may take up to 1-2 visits (\\~ 2 hours each) for different combinations of hearing aid features. The device will only be worn in the laboratory for the duration of the experimental task and will be retrieved by the investigator at the end of each visit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['hearing aids', 'directional microphones', 'cognition', 'compression'], 'conditions': ['Hearing Loss, Sensorineural']}, 'referencesModule': {'references': [{'pmid': '39620655', 'type': 'DERIVED', 'citation': 'Rallapalli V, Freyman R, Souza P. Relationship Between Working Memory, Compression, and Beamformers in Ideal Conditions. Ear Hear. 2025 Mar-Apr 01;46(2):523-536. doi: 10.1097/AUD.0000000000001605. Epub 2024 Nov 6.'}]}, 'descriptionModule': {'briefSummary': "The goal of this project is to determine whether the selection of hearing aid settings should be based in part on an individual's cognitive characteristics (specifically, working memory). We anticipate the outcomes of this study to be applicable to realistic listening conditions.", 'detailedDescription': 'Hearing aids have specialized features to improve access to sounds for the hearing-impaired listener. The choice of appropriate hearing aid settings is integral to the hearing rehabilitative process. Researchers and clinicians have been influenced by previous work showing that individual cognitive abilities, including working memory, are associated with hearing aid benefit, especially in adverse listening conditions. However, previous research is limited to omnidirectional microphone settings and unrealistic listening conditions. Such conditions fail to recognize that most hearing aids are fit with directional processing that may improve the listening environment, and that typical environments contain speech and noise signals in a range of spatial locations. Therefore, the broad goal of this research is to understand how patient variables interact with hearing aid signal processing in realistic listening conditions in order to effectively treat hearing-impaired individuals in communications situations that are most important to them.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> =18 years of age; any sex\n* Sensorineural hearing loss with pure-tone thresholds between 25-70 decibel hearing level (dB HL) at octave frequencies between 250 and 3000 Hz\n* Speak English as their primary language\n* Normal or corrected-to-normal vision (\\<=20/50)\n* Participants will be in good health (self-report)\n\nExclusion Criteria:\n\n* Clinically significant unstable or progressive medical conditions\n* Participants who score \\< 23 on the cognitive screening test (Montreal Cognitive Assessment)\n* Evidence of conductive hearing loss or middle ear issues\n* Significant history of otologic or neurologic disorders\n* Evidence of significant asymmetry between ears\n* Non-English-speaking or non-native English speaking'}, 'identificationModule': {'nctId': 'NCT04521166', 'acronym': 'DIRWDRCWM', 'briefTitle': 'Hearing Aid Processing and Working Memory in Realistic Spatial Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Investigating the Relationship Between Directional Microphones, Compression, and Working Memory in Realistic Spatial Conditions.', 'orgStudyIdInfo': {'id': 'STU00210459'}, 'secondaryIdInfos': [{'id': 'K01DC018324', 'link': 'https://reporter.nih.gov/quickSearch/K01DC018324', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Setting 1', 'description': 'Hearing aid features presented in this arm include omnidirectional microphone settings and fast-acting compression', 'interventionNames': ['Device: Hearing aid']}, {'type': 'EXPERIMENTAL', 'label': 'Setting 2', 'description': 'Hearing aid features presented in this arm include omnidirectional microphone settings and slow-acting compression', 'interventionNames': ['Device: Hearing aid']}, {'type': 'EXPERIMENTAL', 'label': 'Setting 3', 'description': 'Hearing aid features presented in this arm include directional microphone settings and fast-acting compression', 'interventionNames': ['Device: Hearing aid']}, {'type': 'EXPERIMENTAL', 'label': 'Setting 4', 'description': 'Hearing aid features presented in this arm include directional microphone settings and slow-acting compression', 'interventionNames': ['Device: Hearing aid']}], 'interventions': [{'name': 'Hearing aid', 'type': 'DEVICE', 'description': 'Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.', 'armGroupLabels': ['Setting 1', 'Setting 2', 'Setting 3', 'Setting 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60208', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}], 'overallOfficials': [{'name': 'Varsha Rallapalli, AuD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pamela Souza', 'investigatorAffiliation': 'Northwestern University'}}}}