MedDataX Logo

Hearing Loss and Genetic Risks for Alzheimer's Disease and Related Dementia

NCT ID: NCT07288463

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2027-07-01

Study Completion Date

2031-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hearing Loss, Adult-Onset Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Immediate Intervention

Immediate Intervention: 4-month of OTC hearing aid use

Group Type EXPERIMENTAL

Over-The-Counter (OTC) hearing aid

Intervention Type DEVICE

Over-The-Counter (OTC) hearing aid

Waitlist control

Waitlist control: Basic patient education on hearing loss without OTC hearing aid for 2 months, followed by 4 months of OTC hearing aid use

Group Type ACTIVE_COMPARATOR

Over-The-Counter (OTC) hearing aid

Intervention Type DEVICE

Over-The-Counter (OTC) hearing aid

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Over-The-Counter (OTC) hearing aid

Over-The-Counter (OTC) hearing aid

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Janet Choi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Southern California

Los Angeles, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Janet Choi, MD

Role: CONTACT

Phone: 323-790-6788

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Janet Choi, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

APP-25-05793

Identifier Type: -

Identifier Source: org_study_id