HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms

NCT ID: NCT06930560

Last Updated: 2025-11-24

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease Dementia Hearing Loss Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Immediate treatment

Group Type EXPERIMENTAL

HEARS-NPS device

Intervention Type DEVICE

Tailored fitting and programming of a personal sound amplifier accompanied by an aural rehabilitation component.

HEARS-NPS program

Intervention Type BEHAVIORAL

Tailored aural rehabilitation for participant and care partner.

Delayed treatment

Group Type PLACEBO_COMPARATOR

HEARS-NPS device

Intervention Type DEVICE

Tailored fitting and programming of a personal sound amplifier accompanied by an aural rehabilitation component.

HEARS-NPS program

Intervention Type BEHAVIORAL

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.

Intervention Type DEVICE

HEARS-NPS program

Tailored aural rehabilitation for participant and care partner.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 60 - 100 years old
* 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

* Current self-reported use of hearing aid or amplification device
* Medical contraindication to use hearing aids ( e.g. draining ears)
* Inability to participate in the 1-month follow up
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Esther Oh, MD, Ph.D.

Role: CONTACT

410-550-0925

Jami Trumbo, MSPH

Role: CONTACT

Facility Contacts

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Esther Oh, MD, PhD

Role: primary

410-550-0925

Peter Hope, BA

Role: backup

410-550-9047

Other Identifiers

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5R01AG076525-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00357244

Identifier Type: -

Identifier Source: org_study_id

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