Recruiting

Hearing Care Intervention

Sponsor:

Johns Hopkins University

Code:

NCT06930560

Conditions

Alzheimer Disease

Dementia

Hearing Loss

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Interventions

HEARS-NPS device

HEARS-NPS program

Study Details

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

Study ID

NCT06930560

Start date

Oct 15, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Immediate treatment

placebo comparator: Delayed treatment

Interventions

HEARS-NPS device

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

HEARS-NPS program

Tailored aural rehabilitation for participant and care partner.

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 and Locations

Central contacts

Esther Oh, MD, Ph.D.

410-550-0925eoh9@jhmi.edu

Jami Trumbo, MSPH

jami.trumbo@jhu.edu

Locations

Johns Hopkins Memory and Alzheimer's Treatment Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Esther Oh, MD, PhD

410-550-0925eoh9@jhmi.edu

Peter Hope, BA

410-550-9047phope3@jh.edu

Principal Investigator:

Esther Oh, MD, PhD

More Information

Sponsor

Johns Hopkins University

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-11-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.