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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06930560
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • HEARS-NPS device — DEVICE
    Tailored fitting and programming of a personal sound amplifier accompanied by an aural rehabilitation component.
  • HEARS-NPS program — BEHAVIORAL
    Tailored aural rehabilitation for participant and care partner.

Study Details

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.

Key Dates

Start date
Oct 15, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Immediate treatment
  • Placebo Comparator: Delayed treatment

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Memory and Alzheimer's Treatment CenterBaltimoreMaryland21224
Esther Oh, MD, PhD
410-550-0925
Peter Hope, BA
410-550-9047
Esther Oh, MD, PhD (PRINCIPAL_INVESTIGATOR)

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