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Hearing Aid

Hearing Aid Fitting for Alzheimer's Disease

N/A
Recruiting
Led By Yu-Hsiang Wu, PhD
Research Sponsored by Yu-Hsiang Wu
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult-onset mild-to-moderate sensorineural hearing loss
A diagnosis of mild or moderate Major Cognitive Disorder (e.g., Alzheimer disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-week post intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial will help determine how effective hearing aids are for people with Alzheimer's Disease and related dementias.

Who is the study for?
This trial is for older adults with mild or moderate cognitive disorders like Alzheimer's, who also have adult-onset mild-to-moderate hearing loss and haven't used hearing aids before. Participants must speak English natively.
What is being tested?
The study tests three ways of fitting hearing aids: by an audiologist, service-only without an audiologist's fine-tuning, and device-only without additional services. It aims to see how these affect the lives of patients with cognitive impairments and their caregivers after 6 weeks.
What are the potential side effects?
Since this trial involves non-medical interventions (hearing aid fittings), traditional side effects are not applicable. However, participants may experience discomfort or dissatisfaction with the hearing aid fit or function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have adult-onset hearing loss that is not severe.
Select...
I have been diagnosed with mild or moderate Alzheimer's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-week post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-week post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Caregiver burden as measured by the "Zarit Burden Interview" (ZBI)
Daily activity as measured by the Lawton Instrumental Activities of Daily Living Scale (IADL)
Hearing aid benefit as measured by the International Outcomes Inventory for Hearing Aids - Significant Other (IOI-HA-SO)
+1 more
Secondary study objectives
Depression as measured using the Geriatric Depression Scale (GDS)
Hearing handicap as measured by Hearing Handicap Inventory for the Elderly - Spouse (HHIE-SP)
Quality of life as measured by the Alzheimer's Disease-Related Quality of Life (ADRQL)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Service-OnlyExperimental Treatment1 Intervention
In this group, hearing aids that have minimum amplification will be fitted by audiologists.
Group II: Device-OnlyExperimental Treatment1 Intervention
In this group, hearing aids will be provided with minimum services from audiologists.
Group III: Audiologist-BasedActive Control1 Intervention
In this group, the audiologist-based fitting will be used to provide hearing aids.

Find a Location

Who is running the clinical trial?

Yu-Hsiang WuLead Sponsor
3 Previous Clinical Trials
684 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
908 Previous Clinical Trials
934,810 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
361 Previous Clinical Trials
182,028 Total Patients Enrolled
Yu-Hsiang Wu, PhDPrincipal Investigator - University of Iowa
University of Iowa
3 Previous Clinical Trials
684 Total Patients Enrolled

Media Library

Hearing Aid (Hearing Aid) Clinical Trial Eligibility Overview. Trial Name: NCT04049643 — N/A
Age-Related Hearing Loss Research Study Groups: Audiologist-Based, Service-Only, Device-Only
Age-Related Hearing Loss Clinical Trial 2023: Hearing Aid Highlights & Side Effects. Trial Name: NCT04049643 — N/A
Hearing Aid (Hearing Aid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04049643 — N/A
~2 spots leftby May 2025
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