Hearing care to reduce neuropsychiatric symptoms in people with Alzheimer's and related dementias
HEARS Neuropsychiatric Symptoms & Hearing Loss: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
This trial will try a tailored, community-delivered hearing care program using HEARS devices to see if it improves communication, reduces neuropsychiatric symptoms, and eases caregiver distress in English-speaking older adults with Alzheimer's disease or related dementias who have untreated hearing loss.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 60 Years to 100 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06930560 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial delivers a revised, community-based hearing care intervention (HEARS-NPS device and program) to older adults with probable Alzheimer's disease or related dementias and untreated adult-onset hearing loss. Participants are randomized to receive the tailored hearing intervention, which is administered with caregiver involvement and includes device fitting and communication strategies. Study outcomes focus on changes in communication, neuropsychiatric symptoms, and care partner distress, with a required one-month follow-up visit. The intervention is offered through the Johns Hopkins Memory and Alzheimer's Treatment Center and targets real-world, community implementation.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 60–100 with probable Alzheimer's disease or a related dementia, untreated adult-onset hearing loss (speech-frequency PTA >25 dB in the better ear), an available caregiver/study partner aged 18 or older to join visits, and stable neuropsychiatric medication dosing.
Not a fit: Patients already using hearing aids, those with medical contraindications to hearing aid use (for example, draining ears), those unable to complete the required one-month follow-up, or whose symptoms are primarily non-auditory may not receive benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could improve communication, reduce neuropsychiatric symptoms, and lessen caregiver distress by making hearing care more accessible and tailored for people with dementia.
How similar studies have performed: Prior research shows hearing interventions can improve communication, mood, and social engagement, but there is limited and mixed evidence specifically on whether community-delivered hearing care reduces neuropsychiatric symptoms in people with dementia.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Memory and Alzheimer's Treatment Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Esther Oh, MD, PhD — Johns Hopkins University
- Study coordinator: Esther Oh, MD, Ph.D.
- Email: eoh9@jhmi.edu
- Phone: 410-550-0925
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.