HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
NCT ID: NCT06930560
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2025-10-15
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Immediate treatment
HEARS-NPS device
Tailored fitting and programming of a personal sound amplifier accompanied by an aural rehabilitation component.
HEARS-NPS program
Tailored aural rehabilitation for participant and care partner.
Delayed treatment
HEARS-NPS device
Tailored fitting and programming of a personal sound amplifier accompanied by an aural rehabilitation component.
HEARS-NPS program
Tailored aural rehabilitation for participant and care partner.
Interventions
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HEARS-NPS device
Tailored fitting and programming of a personal sound amplifier accompanied by an aural rehabilitation component.
HEARS-NPS program
Tailored aural rehabilitation for participant and care partner.
Eligibility Criteria
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Inclusion Criteria
* English-speaking
* 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
* Speech frequency pure tone average (0.5- 4 kHz) \>25 db in the better-hearing ear; adult onset hearing loss
* Availability of caregiver/study partner who is 18+ to participate in all study-related visits and who provides care supervision
* Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms
Exclusion Criteria
* Medical contraindication to use hearing aids ( e.g. draining ears)
* Inability to participate in the 1-month follow up
60 Years
100 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Esther Oh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Memory and Alzheimer's Treatment Center
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00357244
Identifier Type: -
Identifier Source: org_study_id
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