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

November 21, 2025 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

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 Contact

Study Contact Backup

  • Name: Esther Oh, MD, Ph.D.
  • Phone Number: 410-550-0925
  • Email: eoh9@jhmi.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Johns Hopkins Memory and Alzheimer's Treatment Center
        • Contact:
          • Esther Oh, MD, PhD
          • Phone Number: 410-550-0925
          • Email: eoh9@jhmi.edu
        • Contact:
        • Principal Investigator:
          • Esther Oh, MD, PhD

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
  • 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

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
Device: HEARS-NPS device
Tailored fitting and programming of a personal sound amplifier accompanied by an aural rehabilitation component.
Behavioral: HEARS-NPS program
Tailored aural rehabilitation for participant and care partner.
Placebo Comparator: Delayed treatment
Device: HEARS-NPS device
Tailored fitting and programming of a personal sound amplifier accompanied by an aural rehabilitation component.
Behavioral: HEARS-NPS program
Tailored aural rehabilitation for participant and care partner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distress as assessed by the Neuropsychiatric Inventory (NPI-Q)
Time Frame: Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months 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 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

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, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing Handicap Inventory for the Elderly (HHIE-S)
Time Frame: Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months 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, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)
Relationship Quality as assessed by the Patient-Caregiver Closeness Scale (CG-CR)
Time Frame: Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)
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.
Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)
International Outcome Inventory for Hearing Aids (IOI-HA) Survey
Time Frame: Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months post-baseline (Delayed Group)
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.
Baseline, 6-week, 3-month, and 6-months post-intervention (immediate group). Baseline, 6-week, 3-month, and 6-months 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 University

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)

October 15, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00357244
  • 5R01AG076525-02 (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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