Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-01 @ 10:10 PM
Study NCT ID:
NCT03338751
Status:
WITHDRAWN
Last Update Posted:
2017-11-09
First Post:
2017-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unfunded Pilot Study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-08', 'studyFirstSubmitDate': '2017-10-27', 'studyFirstSubmitQcDate': '2017-11-08', 'lastUpdatePostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of Cognitive function using Mini-Cog', 'timeFrame': '20 Minutes', 'description': 'three-item recall and a clock draw test. 24 Medical assistants have been trained and have employed this test successfully in primary care practices. The Mini-Cog has test characteristics that are comparable to any other brief instrument and exceeds most in accuracy or predictive quality.'}, {'measure': 'Perceived Hearing measured by Hearing Handicap Inventory for the Elderly-Screening Version (HHIE)', 'timeFrame': '20 Minutes', 'description': 'HHIE-S is a valid, robust test for identifying hearing-impaired elderly, irrespective of the audiometric definition used to finally diagnose hearing difficulties.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hearing Impairment']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to see if a commercially available hearing assistance device called the PockeTalker has an effect on performance on cognitive (memory and thinking) tests among skilled nursing facility residents.\n\nInvestigators are asking residents to perform cognitive tests with and without hearing assistance equipment known as PockeTalkers. This study will be conducted at one urban Skilled Nursing Facility (SNF) with the goal of understanding the extent to which hearing impairment impacts commonly used cognitive impairment measures for clinical assessment. Cognitive performance will be measured, cerumen occlusion, and perceived hearing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admitted to unit of intervention\n* ability to communicate and follow simple commands\n* capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.\n\nExclusion Criteria:\n\n* not on the unit of intervention\n* obtunded or comatose state\n* inability to communicate verbally\n* inability to consent and without surrogate\n* non-English speaking'}, 'identificationModule': {'nctId': 'NCT03338751', 'acronym': 'DECIPHER', 'briefTitle': 'Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents', 'orgStudyIdInfo': {'id': '17-00697'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hearing Assistance Device (HAD) First', 'description': 'Tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second. Participants randomized to HAD first will use a Hearing Aid Device.', 'interventionNames': ['Diagnostic Test: cognitive testing with HAD (PockeTalker) First', 'Diagnostic Test: Cognitive testing without HAD First']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Hearing Assistance Device (HAD) First', 'description': 'Sham hearing aid device', 'interventionNames': ['Diagnostic Test: cognitive testing with HAD (PockeTalker) First', 'Diagnostic Test: Cognitive testing without HAD First']}], 'interventions': [{'name': 'cognitive testing with HAD (PockeTalker) First', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['PockeTalker Hearing Aid Device'], 'description': 'tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.', 'armGroupLabels': ['Hearing Assistance Device (HAD) First', 'No Hearing Assistance Device (HAD) First']}, {'name': 'Cognitive testing without HAD First', 'type': 'DIAGNOSTIC_TEST', 'description': 'tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.', 'armGroupLabels': ['Hearing Assistance Device (HAD) First', 'No Hearing Assistance Device (HAD) First']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Joshua Chodosh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}