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

NCT06930560 | Recruiting

• 2 other identifiers: IRB003572445R01AG076525-02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease; Dementia; Hearing Loss; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Distress as assessed by the Neuropsychiatric Inventory (NPI-Q)

  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 Outcomes (3)

• Hearing Handicap Inventory for the Elderly (HHIE-S)

  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)

  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

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

Study Arms (2)

Immediate treatment

EXPERIMENTAL

Device: HEARS-NPS device; Behavioral: HEARS-NPS program

Delayed treatment

PLACEBO COMPARATOR

Device: HEARS-NPS device; Behavioral: HEARS-NPS program

Interventions

HEARS-NPS device DEVICE

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

Delayed treatment; Immediate treatment

HEARS-NPS program BEHAVIORAL

Tailored aural rehabilitation for participant and care partner.

Delayed treatment; Immediate treatment

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Johns Hopkins Memory and Alzheimer's Treatment Center

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Hearing Loss; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders

Study Officials

• Esther Oh, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther Oh, MD, Ph.D.

CONTACT

410-550-0925; eoh9@jhmi.edu

Jami Trumbo, MSPH

CONTACT

jami.trumbo@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)