Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT03402932
Status:
COMPLETED
Last Update Posted:
2019-04-03
First Post:
2018-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Administration Method of Cognitive Screening in Older Individuals With Hearing Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jing.shen@wmich.edu', 'phone': '2693878067', 'title': 'Jing Shen', 'organization': 'Western Michigan University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The outcome measures are behavioral measures (e.g., cognitive screening test scores) and were collected within a short period of time (2 hours).', 'description': 'All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Group1: Younger Auditory Unamplified - Visual', 'description': 'All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group2: Auditory Amplified - Visual', 'description': 'All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group3: Auditory Amplified - Unamplified', 'description': 'All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group4: Auditory Unamplified - Visual', 'description': 'All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cognitive Screening Results (Montreal Cognitive Assessment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group1: Auditory Unamplified -Visual (Younger Adults)', 'description': 'Younger adults with normal hearing group was included to validate the visual version of the test.\n\nThe auditory administration was unamplified. The visual administration had all test material visually presented.'}, {'id': 'OG001', 'title': 'Group2: Amplified-Visual (Older Adults w/ Hearing Loss)', 'description': "Auditory amplified: The cognitive test was administered using a computer-based signal processing to amplify the instruction. The presentation level was customized to the individual's hearing thresholds.\n\nVisual administration presented all test material visually."}, {'id': 'OG002', 'title': 'Group3: Amplified-Unamplified (Older Adults w/ Hearing Loss)', 'description': 'Auditory amplified: The cognitive test was administered by using customized amplification.\n\nAuditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level.'}, {'id': 'OG003', 'title': 'Group4: Visual-Unamplified (Older Adults w/ Hearing Loss)', 'description': 'Visual: The cognitive test was administered visually by using timed computer slides.\n\nAuditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level.'}], 'classes': [{'title': 'Condition 1', 'categories': [{'measurements': [{'value': '28.69', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '22.37', 'spread': '2.82', 'groupId': 'OG001'}, {'value': '23.375', 'spread': '2.34', 'groupId': 'OG002'}, {'value': '23', 'spread': '2.82', 'groupId': 'OG003'}]}]}, {'title': 'Condition 2', 'categories': [{'measurements': [{'value': '28.30', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '23.5', 'spread': '2.91', 'groupId': 'OG001'}, {'value': '24.125', 'spread': '1.26', 'groupId': 'OG002'}, {'value': '22.12', 'spread': '2.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The outcome measure was assessed immediately after the test. This applies to both conditions for all the arms.', 'description': 'The cognitive screening test of Montreal Cognitive Assessment (MoCA) was administered to 4 groups with different administration method conditions (see arms/groups table).\n\nMoCA is s standardized cognitive screening tool for mild cognitive impairment and dementia. The total score was used as outcome measure of this study and this score ranges from 0-30, with higher score being better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Auditory Working Memory Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group1: Younger Control (Auditory Unamplified - Visual)', 'description': 'This arm is for validating the visual version of the tests with younger individuals with normal hearing.\n\nVisual: The cognitive test was administered visually by using timed computer slides.\n\nAuditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level.'}, {'id': 'OG001', 'title': 'Group2: Auditory Amplified - Visual', 'description': "Auditory amplified: The cognitive test was administered using a computer-based signal processing to amplify the instruction. The presentation level was customized to the individual's hearing thresholds.\n\nVisual: The cognitive test was administered visually by using timed computer slides."}, {'id': 'OG002', 'title': 'Group3: Auditory Amplified - Unamplified', 'description': "Auditory amplified: The cognitive test was administered using a computer-based signal processing to amplify the instruction. The presentation level was customized to the individual's hearing thresholds.\n\nAuditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level."}, {'id': 'OG003', 'title': 'Group4: Auditory Unamplified - Visual', 'description': 'Visual: The cognitive test was administered visually by using timed computer slides.\n\nAuditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level.'}], 'classes': [{'title': 'Condition 1', 'categories': [{'measurements': [{'value': '82.88', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '72.3', 'spread': '7.1', 'groupId': 'OG001'}, {'value': '69.1', 'spread': '8.2', 'groupId': 'OG002'}, {'value': '57.5', 'spread': '11.5', 'groupId': 'OG003'}]}]}, {'title': 'Condition 2', 'categories': [{'measurements': [{'value': '82.11', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '66.9', 'spread': '9.66', 'groupId': 'OG001'}, {'value': '64.5', 'spread': '11.4', 'groupId': 'OG002'}, {'value': '61.3', 'spread': '14.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The outcome measure will be assessed immediately after the test.', 'description': 'Older individuals were presented with lists of words and instructed to repeat them back. After each word list, they had to recall the words.', 'unitOfMeasure': 'percentage of correct recall', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group1: Auditory -Visual (Younger Adults w/ Normal Hearing)', 'description': 'A group of younger adults with normal hearing is included to validate the visual version of the tests'}, {'id': 'FG001', 'title': 'Group2: Amplified-Visual (Older Adults w/ Hearing Loss)', 'description': "Auditory amplified: The cognitive test was administered using a computer-based signal processing to amplify the instruction. The presentation level was customized to the individual's hearing thresholds.\n\nVisual: The cognitive test was administered visually by using timed computer slides."}, {'id': 'FG002', 'title': 'Group3: Amplified-Unamplified (Older Adults w/ Hearing Loss)', 'description': "Auditory amplified: The cognitive test was administered using a computer-based signal processing to amplify the instruction. The presentation level was customized to the individual's hearing thresholds.\n\nAuditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level."}, {'id': 'FG003', 'title': 'Group4: Visual-Unamplified (Older Adults w/ Hearing Loss)', 'description': 'Visual: The cognitive test was administered visually by using timed computer slides.\n\nAuditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'No significant event after andnrollment, prior to assignment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group1: Younger Control (Auditory Unamplified - Visual)', 'description': 'This arm is for validating the visual version of the tests with younger individuals with normal hearing.\n\nVisual: The cognitive test was administered visually by using timed computer slides.\n\nAuditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level.'}, {'id': 'BG001', 'title': 'Group2: Auditory Amplified - Visual', 'description': "Auditory amplified: The cognitive test was administered using a computer-based signal processing to amplify the instruction. The presentation level was customized to the individual's hearing thresholds.\n\nVisual: The cognitive test was administered visually by using timed computer slides."}, {'id': 'BG002', 'title': 'Group3: Auditory Amplified - Unamplified', 'description': "Auditory amplified: The cognitive test was administered using a computer-based signal processing to amplify the instruction. The presentation level was customized to the individual's hearing thresholds.\n\nAuditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level."}, {'id': 'BG003', 'title': 'Group4: Auditory Unamplified - Visual', 'description': 'Visual: The cognitive test was administered visually by using timed computer slides.\n\nAuditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level.'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.69', 'spread': '2.78', 'groupId': 'BG000'}, {'value': '77', 'spread': '5.91', 'groupId': 'BG001'}, {'value': '73.37', 'spread': '4.12', 'groupId': 'BG002'}, {'value': '73.75', 'spread': '6.35', 'groupId': 'BG003'}, {'value': '28.5', 'spread': '1.18', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-25', 'size': 42062, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-11-26T22:34', 'hasProtocol': False}, {'date': '2019-02-01', 'size': 198189, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-07T15:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2018-01-04', 'resultsFirstSubmitDate': '2018-08-22', 'studyFirstSubmitQcDate': '2018-01-17', 'lastUpdatePostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-11', 'studyFirstPostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Screening Results (Montreal Cognitive Assessment)', 'timeFrame': 'The outcome measure was assessed immediately after the test. This applies to both conditions for all the arms.', 'description': 'The cognitive screening test of Montreal Cognitive Assessment (MoCA) was administered to 4 groups with different administration method conditions (see arms/groups table).\n\nMoCA is s standardized cognitive screening tool for mild cognitive impairment and dementia. The total score was used as outcome measure of this study and this score ranges from 0-30, with higher score being better performance.'}], 'secondaryOutcomes': [{'measure': 'Auditory Working Memory Performance', 'timeFrame': 'The outcome measure will be assessed immediately after the test.', 'description': 'Older individuals were presented with lists of words and instructed to repeat them back. After each word list, they had to recall the words.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss, Sensorineural', 'Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '27115241', 'type': 'BACKGROUND', 'citation': 'Jorgensen LE, Palmer CV, Pratt S, Erickson KI, Moncrieff D. The Effect of Decreased Audibility on MMSE Performance: A Measure Commonly Used for Diagnosing Dementia. J Am Acad Audiol. 2016 Apr;27(4):311-23. doi: 10.3766/jaaa.15006.'}, {'pmid': '28559106', 'type': 'BACKGROUND', 'citation': 'Guerreiro MJS, Van Gerven PWM. Disregarding hearing loss leads to overestimation of age-related cognitive decline. Neurobiol Aging. 2017 Aug;56:180-189. doi: 10.1016/j.neurobiolaging.2017.05.001. Epub 2017 May 10.'}, {'pmid': '23337978', 'type': 'BACKGROUND', 'citation': 'Lin FR, Yaffe K, Xia J, Xue QL, Harris TB, Purchase-Helzner E, Satterfield S, Ayonayon HN, Ferrucci L, Simonsick EM; Health ABC Study Group. Hearing loss and cognitive decline in older adults. JAMA Intern Med. 2013 Feb 25;173(4):293-9. doi: 10.1001/jamainternmed.2013.1868.'}, {'pmid': '25325767', 'type': 'BACKGROUND', 'citation': 'Dupuis K, Pichora-Fuller MK, Chasteen AL, Marchuk V, Singh G, Smith SL. Effects of hearing and vision impairments on the Montreal Cognitive Assessment. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2015;22(4):413-37. doi: 10.1080/13825585.2014.968084. Epub 2014 Oct 17.'}]}, 'descriptionModule': {'briefSummary': "The objectives of the current project aim to determine whether a more controlled amplification method or a visual administration has an effect on hearing impaired older individuals' cognitive test scores.", 'detailedDescription': 'Aim 1 is to create a visually administered condition of a cognitive test and to validate this condition in comparison to the auditory administration. Data will be collected from younger individuals with normal hearing. Each younger individual is tested using both visual and auditory condition and the scores are compared across the two conditions. It is anticipated that the scores will not be significantly different between the two conditions.\n\nAim 2 is to examine the test condition effect on cognitive testing results in older individuals with hearing loss. The three test conditions include auditory unamplified, auditory amplified, and visual. Each older individual will be tested using two different test conditions. It is predicted the auditory amplified and visual administrations will alleviate the cognitive load associated with hearing difficulty and lead to improved performance on the test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have sensorineural hearing loss\n* Have normal or corrected-to-normal vision\n\nExclusion Criteria:\n\n* Have conductive hearing loss;\n* Have history of otologic or neurologic disorders\n* Have dementia\n* Non-native speakers of English'}, 'identificationModule': {'nctId': 'NCT03402932', 'briefTitle': 'Administration Method of Cognitive Screening in Older Individuals With Hearing Loss', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'The Impact of Test Administration Method on Cognitive Screening Results in Older Individuals With Hearing Loss', 'orgStudyIdInfo': {'id': '2R01DC012289', 'link': 'https://reporter.nih.gov/quickSearch/2R01DC012289', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Auditory Amplified-Visual', 'description': 'This arm is designed to test the contrast between auditory amplified and visual conditions.', 'interventionNames': ['Other: Auditory amplified', 'Other: Visual']}, {'type': 'EXPERIMENTAL', 'label': 'Auditory Amplified-Unamplified', 'description': 'This arm is designed to test the contrast between auditory amplified and unamplified conditions.', 'interventionNames': ['Other: Auditory amplified', 'Other: Auditory unamplified']}, {'type': 'EXPERIMENTAL', 'label': 'Auditory Unamplified-Visual', 'description': 'This arm is designed to test the contrast between auditory unamplified and visual conditions.', 'interventionNames': ['Other: Visual', 'Other: Auditory unamplified']}, {'type': 'OTHER', 'label': 'Younger control group', 'description': 'This arm is designed to validate the visual version by comparing to the auditory version in a group of younger normal hearing controls.', 'interventionNames': ['Other: Visual', 'Other: Auditory unamplified']}], 'interventions': [{'name': 'Auditory amplified', 'type': 'OTHER', 'description': "The cognitive test will be administered using a computer-based signal processing to amplify the instruction. The presentation level is customized to the individual's hearing thresholds.", 'armGroupLabels': ['Auditory Amplified-Unamplified', 'Auditory Amplified-Visual']}, {'name': 'Visual', 'type': 'OTHER', 'description': 'The cognitive test will be administered visually by using timed computer slides.', 'armGroupLabels': ['Auditory Amplified-Visual', 'Auditory Unamplified-Visual', 'Younger control group']}, {'name': 'Auditory unamplified', 'type': 'OTHER', 'description': 'The cognitive test will be administered by using a generic presentation level that simulates a normal conversational level.', 'armGroupLabels': ['Auditory Amplified-Unamplified', 'Auditory Unamplified-Visual', 'Younger control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60208', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hearing Aid Laboratory', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The results will be shared in the form of presentations and publications. Study protocol is available upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Jing Shen', 'investigatorAffiliation': 'Northwestern University'}}}}