Hearing Loss and Brain Health Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT07288463
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Dementia
  • Hearing Loss, Adult-Onset

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Over-The-Counter (OTC) hearing aid — DEVICE
    Over-The-Counter (OTC) hearing aid

Study Details

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. 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: 3-mo using OTC hearing aids or (2) waitlist control: 3-mo without devices followed by OTC hearing aid use after 3 months. 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 listening efforts. Findings will inform the design of larger trials aimed at improving access to hearing care and promoting cognitive health.

Key Dates

Start date
Jul 1, 2027
Status verified
May 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Immediate Intervention
    Immediate Intervention: 3-month of OTC hearing aid use
  • Active Comparator: Waitlist control
    Waitlist control: Basic patient education on hearing loss without OTC hearing aid for 3 months, followed by OTC hearing aid fitting

Primary Outcome Measure

Feasibility- Proportion of enrolled participants who complete all study periods [ Time Frame: Baseline, 3 months, and 6 months follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90066
Janet Choi, MD
[email protected]
323-790-6788

Find similar trials in Los Angeles, CA

By research site
University of Southern California· Los Angeles, CA

Related Studies