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

February 25, 2026 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate treatment
immediate treatment
Device: HEARS-SLP device
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Behavioral: HEARS-SLP program
Tailored aural rehabilitation for participant and communication partner
Placebo Comparator: Delayed treatment
1 month delayed treatment
Device: HEARS-SLP device
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
Behavioral: HEARS-SLP program
Tailored aural rehabilitation for participant and communication partner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Neuropsychiatric Symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q)
Time Frame: Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)

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 on them 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.

SEVERITY of the symptom (how it affects the patient):

  1. = Mild (noticeable, but not a significant change)
  2. = Moderate (significant, but not a dramatic change)
  3. = Severe
Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Health-related Quality of Life as assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) scale
Time Frame: Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)

Scoring for QOL-AD:

Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.

The total score is the sum of all 13 items. Total scores range from 13 to 52.
Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)
Change From Baseline in Hearing Specific Quality of life as assessed by the Hearing Handicap Inventory for the Elderly (HHIE-S)
Time Frame: Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)

Higher scores indicate increased hearing handicap.

Scoring:

0-8 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.
Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Esther Oh, MD, PhD, Johns Hopkins School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2023

Primary Completion (Actual)

February 24, 2026

Study Completion (Actual)

February 24, 2026

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00218068
  • K23AG059900 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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