HEARS-SLP: Providing SLP-Delivered Hearing Health Care to Individuals With Cognitive Impairment

NCT ID: NCT06008782

Last Updated: 2026-01-28

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-15

Study Completion Date

2026-02-28

Brief Summary

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Building upon the HEARS audiologist-community health worker (CHW) model, this study intervention will be delivered by a speech-language pathologist (SLP). The primary objective of the study is to develop and test an affordable and accessible hearing rehabilitative intervention that will be delivered by a SLP to individuals with cognitive impairment.

Detailed Description

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Conditions

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Hearing Loss Dementia 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

immediate treatment

Group Type EXPERIMENTAL

HEARS-SLP device

Intervention Type DEVICE

Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

HEARS-SLP program

Intervention Type BEHAVIORAL

Tailored aural rehabilitation for participant and communication partner

Delayed treatment

1 month delayed treatment

Group Type PLACEBO_COMPARATOR

HEARS-SLP device

Intervention Type DEVICE

Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

HEARS-SLP program

Intervention Type BEHAVIORAL

Tailored aural rehabilitation for participant and communication partner

Interventions

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HEARS-SLP device

Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

Intervention Type DEVICE

HEARS-SLP program

Tailored aural rehabilitation for participant and communication partner

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 60 - 100 years old
* English-speaking
* Lives at home
* 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
* Availability of caregiver/study partner to participate in all study-related visits and who provides ≥8 hours of weekly oversight/care
* Speech frequency pure tone average (0.5- 4 kHz) \>25 db in the better-hearing ear; adult onset hearing loss
* 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 School of Medicine

Locations

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Johns Hopkins Medicine

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Carrie L Nieman, MD, MPH

Role: CONTACT

410-502-6965

Jami Trumbo, MSPH

Role: CONTACT

410-955-0920

Facility Contacts

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Esther Oh, MD, PhD

Role: primary

410-550-0925

Other Identifiers

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K23AG059900

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00218068

Identifier Type: -

Identifier Source: org_study_id

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