CompletedNot Applicable

Hearing Aid and Individuals With Cognitive Disorders

United States17 participantsStarted 2019-12-01

Plain-language summary

This is a pilot study with the aim of evaluating the feasibility of the procedures of a future clinical trial that will help determine the impacts of hearing aid interventions on older patients with Alzheimer's Disease and related dementias (ADRD). In this pilot study individuals with mild or moderate cognitive impairment, as well as their caregivers, will be recruited. Participants will be randomly assigned to three intervention groups: Audiologist-Based Intervention, Service-Only Group, and Device-Only Group. Outcome data will be collected on the how hearing loss and hearing aid impact their lives and caregiver burden 6-week post hearing aid intervention.

Who can participate

Age range

55 Years – 85 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: * Montreal Cognitive Assessment (MoCA) score lower than 25 points * Adult-onset mild-to-moderate sensorineural hearing loss Exclusion Criteria: * Non-native English speaker * Prior hearing aid experience

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

Hearing Aid Benefit as Measured by the International Outcomes Inventory for Hearing Aids (IOI-HA)

Timeframe: 6 weeks after the first day participants started using hearing aids.

Change of Daily Activity as Measured by the Lawton Instrumental Activities of Daily Living Scale (IADL)

Timeframe: Immediately before hearing aid use and 6 weeks after the first day of hearing aid use

Change of Caregiver Burden as Measured by the "Zarit Burden Interview" (ZBI)

Timeframe: Immediately before hearing aid use and 6 weeks after the first day of hearing aid use

Trial details

NCT IDNCT04049643

SponsorYu-Hsiang Wu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-07

Results submitted2025-03-18

View on ClinicalTrials.gov More Presbycusis, Bilateral trials

Plain-language summary

Who can participate

Age range

55 Years – 85 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.

What they're measuring

Hearing Aid Benefit as Measured by the International Outcomes Inventory for Hearing Aids (IOI-HA)

Timeframe: 6 weeks after the first day participants started using hearing aids.

Change of Daily Activity as Measured by the Lawton Instrumental Activities of Daily Living Scale (IADL)

Timeframe: Immediately before hearing aid use and 6 weeks after the first day of hearing aid use

Change of Caregiver Burden as Measured by the "Zarit Burden Interview" (ZBI)

Timeframe: Immediately before hearing aid use and 6 weeks after the first day of hearing aid use