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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-week post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-week post intervention
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 moreSecondary 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.
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Who is running the clinical trial?
Yu-Hsiang WuLead Sponsor
3 Previous Clinical Trials
684 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
900 Previous Clinical Trials
939,476 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
352 Previous Clinical Trials
181,159 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not speak English as your first language.You have never used a hearing aid before.I have adult-onset hearing loss that is not severe.I have been diagnosed with mild or moderate Alzheimer's disease.
Research Study Groups:
This trial has the following groups:- Group 1: Audiologist-Based
- Group 2: Service-Only
- Group 3: Device-Only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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