CompletedNot Applicable

HEARS-SLP: Providing SLP-Delivered Hearing Health Care to Individuals With Cognitive Impairment

United States77 participantsStarted 2023-12-15

Plain-language summary

Building upon the HEARS audiologist-community health worker (CHW) model, this study intervention will be delivered by a speech-language pathologist (SLP). The primary objective of the study is to develop and test an affordable and accessible hearing rehabilitative intervention that will be delivered by a SLP to individuals with cognitive impairment.

Who can participate

Age range

60 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 60 - 100 years old * English-speaking * Lives at home * 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 * Availability of caregiver/study partner to participate in all study-related visits and who provides ≥8 hours of weekly oversight/care * Speech frequency pure tone average (0.5- 4 kHz) \>25 db in the better-hearing ear; adult onset hearing loss * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in Neuropsychiatric Symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q)

Timeframe: Baseline and 1 month post-intervention (immediate group). 1 month post-baseline (Delayed Group)

Trial details

NCT IDNCT06008782

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-24

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