Trials / Not Yet Recruiting
Not Yet RecruitingNCT07288463
Hearing Loss and Genetic Risks for Alzheimer's Disease and Related Dementia
Hearing Loss and Genetic Risks for Dementia
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- University of Southern California · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
Hearing loss is a prevalent and modifiable risk factor for cognitive decline and dementia in older adults, yet access to hearing care remains limited. Over-the-counter (OTC) hearing aids represent a promising and scalable strategy to expand access, particularly for individuals at elevated risk for dementia who may benefit most from earlier intervention. This pilot study aims to evaluate the feasibility and acceptability of OTC hearing aid use among older adults at increased risk for dementia. Participants aged ≥50 years will undergo standardized hearing screening to identify bilateral, mild-to-moderate hearing loss. Eligible participants will be randomized to one of two sequences: (1) immediate intervention: 4-mo using OTC hearing aids or (2) waitlist control: 2-mo without devices followed by an additional 4-mo using OTC hearing aids. Feasibility outcomes include study enrollment and retention, protocol adherence, and average daily device use determined by data-logging. Acceptability outcomes will be assessed using the International Outcome Inventory for Hearing Aids (IOI-HA), device satisfaction ratings, and participant intention to continue hearing-aid use. Hearing outcomes include validated questionnaires on hearing and listenign efforts. Findings will inform the design of larger trials aimed at improving access to hearing care and promoting cognitive health in high-risk older adults.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Over-The-Counter (OTC) hearing aid | Over-The-Counter (OTC) hearing aid |
Timeline
- Start date
- 2027-07-01
- Primary completion
- 2030-06-30
- Completion
- 2031-06-30
- First posted
- 2025-12-17
- Last updated
- 2025-12-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07288463. Inclusion in this directory is not an endorsement.