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
- Alzheimer Disease
- Cognitive Impairment
- Dementia
- Hearing Loss
Eligibility Criteria
- Sex
- ALL
- Age
- 60 Years - 100 Years
- Healthy Volunteers
- Accepted
Interventions
- HEARS-NPS device — DEVICETailored fitting and programming of a personal sound amplifier accompanied by an aural rehabilitation component.
- HEARS-NPS program — BEHAVIORALTailored 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
- Esther Oh, MD, Ph.D.410-550-0925
- Jami Trumbo, MSPH
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Johns Hopkins Memory and Alzheimer's Treatment Center | Baltimore | Maryland | 21224 | Esther Oh, MD, PhD (PRINCIPAL_INVESTIGATOR) |
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