NCT07288463 · NOT YET RECRUITING
Hearing Loss and Genetic Risks for Alzheimer's Disease and Related Dementia
This pilot study is testing whether over-the-counter hearing aids are practical and acceptable for older adults at high risk for dementia who have mild-to-moderate hearing loss. Participants are randomly assigned to get hearing aids right away or after a short wait. It is a Phase N/A feasibility study — meaning researchers are checking whether a larger trial is even doable, not yet proving the approach works.
You may qualify if
- Age >= 50 years
- APOE ε4 carriers
- Bilateral mild to moderate sensorineural hearing loss
- No current use of hearing aids or cochlear implants
- No diagnosis of dementia and able to provide informed consent
- Able to complete questionnaires and follow instructions in English
- Willing and able to comply with study procedures, follow-up visits, and hearing-aid use
You're excluded if
- Clinical diagnosis of dementia
- Severe or profound hearing loss
- Self-reported congenital hearing loss
- Absence of an ear canal due to medical conditions or prior surgical procedures
- unwillingness to wear OTC hearing aids regularly (>=4 hours/day)
- medical contraindication to use hearing aids (e.g., actively draining ear)
- Known retrocochlear pathology
- Severe uncorrected visual impairment or significant manual dexterity limitations that prevent handling the device
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-12-17