Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-31 @ 2:34 PM
Study NCT ID:
NCT06930560
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2025-04-09', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distress as assessed by the Neuropsychiatric Inventory (NPI-Q)', 'timeFrame': 'Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)', 'description': 'Scoring: Each of the 12 NPI-Q domains contains a survey question that reflects symptoms of that domain. Initial responses to each domain question are "Yes" or "No". If the response to the question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale and the associated impact of the symptom manifestations using a 5-point scale. The NPI-Q provides symptom Severity and Distress ratings for each symptom reported, and total Severity and Distress scores reflecting the sum of individual domain scores. Total NPI-Q severity score is the sum of individual symptom scores, ranges from 0 to 36. Higher score is worse\n\nSEVERITY of the symptom (how it affects the patient):\n\n1. = Mild (noticeable, but not a significant change)\n2. = Moderate (significant, but not a dramatic change)\n3. = Severe'}], 'secondaryOutcomes': [{'measure': 'Hearing Handicap Inventory for the Elderly (HHIE-S)', 'timeFrame': 'Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)', 'description': 'Higher scores indicate increased hearing handicap.\n\nScoring:\n\n0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.'}, {'measure': 'Relationship Quality as assessed by the Patient-Caregiver Closeness Scale (CG-CR)', 'timeFrame': 'Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)', 'description': 'The scale assesses the closeness of the caregiver-care recipient relationship with six items. The total score ranges from 14 to 70. A higher total score reflects a better relationship quality.'}, {'measure': 'International Outcome Inventory for Hearing Aids (IOI-HA) Survey', 'timeFrame': 'Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)', 'description': 'The hearing inventory survey is used to evaluate the effectiveness of alternative interventions such as assistive devices and communication strategies. The total score ranges from 7-35 where higher scores indicate a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease', 'Dementia', 'Hearing Loss', 'Cognitive Impairment']}, 'descriptionModule': {'briefSummary': "This randomized controlled trial study aims to evaluate a revised hearing care intervention for older adults with Alzheimer's Disease and Related Dementias (ADRD). The community-delivered hearing care intervention utilizes tailored strategies to assess impact on communication, neuropsychiatric symptoms (NPS), and care partner distress."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 60 - 100 years old\n* English-speaking\n* Diagnosis of probable Alzheimer's Disease or other related dementia according to the core clinical criteria outlined in the National Institute on Aging (NIA) and Alzheimer's Association Guidelines\n* Speech frequency pure tone average (0.5- 4 kHz) \\>25 db in the better-hearing ear; adult onset hearing loss\n* Availability of caregiver/study partner who is 18+ to participate in all study-related visits and who provides care supervision\n* Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms\n\nExclusion Criteria:\n\n* Current self-reported use of hearing aid or amplification device\n* Medical contraindication to use hearing aids ( e.g. draining ears)\n* Inability to participate in the 1-month follow up"}, 'identificationModule': {'nctId': 'NCT06930560', 'acronym': 'HEARS-NPS', 'briefTitle': 'HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'HEARS Neuropsychiatric Symptoms & Hearing Loss: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms', 'orgStudyIdInfo': {'id': 'IRB00357244'}, 'secondaryIdInfos': [{'id': '5R01AG076525-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01AG076525-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate treatment', 'interventionNames': ['Device: HEARS-NPS device', 'Behavioral: HEARS-NPS program']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Delayed treatment', 'interventionNames': ['Device: HEARS-NPS device', 'Behavioral: HEARS-NPS program']}], 'interventions': [{'name': 'HEARS-NPS device', 'type': 'DEVICE', 'description': 'Tailored fitting and programming of a personal sound amplifier accompanied by an aural rehabilitation component.', 'armGroupLabels': ['Delayed treatment', 'Immediate treatment']}, {'name': 'HEARS-NPS program', 'type': 'BEHAVIORAL', 'description': 'Tailored aural rehabilitation for participant and care partner.', 'armGroupLabels': ['Delayed treatment', 'Immediate treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Esther Oh, MD, PhD', 'role': 'CONTACT', 'email': 'eoh9@jhmi.edu', 'phone': '410-550-0925'}, {'name': 'Peter Hope, BA', 'role': 'CONTACT', 'email': 'phope3@jh.edu', 'phone': '410-550-9047'}, {'name': 'Esther Oh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Johns Hopkins Memory and Alzheimer's Treatment Center", 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Esther Oh, MD, Ph.D.', 'role': 'CONTACT', 'email': 'eoh9@jhmi.edu', 'phone': '410-550-0925'}, {'name': 'Jami Trumbo, MSPH', 'role': 'CONTACT', 'email': 'jami.trumbo@jhu.edu'}], 'overallOfficials': [{'name': 'Esther Oh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}