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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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)
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
2 Previous Clinical Trials
285 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
856 Previous Clinical Trials
672,162 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
328 Previous Clinical Trials
178,275 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 20 or older eligible for this research?
"Elderly individuals aged 55 or older, but under 85 years of age are eligible for inclusion in this research."
Answered by AI
What is the aggregate patient count in this clinical trial?
"Affirmative. The information on clinicaltrials.gov confirms that this experiment is actively recruiting patients, which was initially posted back in December 2019 and updated lastly in March 2022. There is an urgency to acquire 30 individuals from two different medical centres."
Answered by AI
Am I eligible to join the experiment?
"This clinical trial seeks to enroll 30 individuals with an ApoE4 allele and Alzheimer Disease 2, aged between 55-85. Eligibility criteria include a diagnosis of mild/moderate Major Cognitive Disorder (e.g., AD2), adult onset sensorineural hearing loss, and no prior experience using hearing aids."
Answered by AI
Are there any pertinent openings for participation in this trial?
"Affirmative. Data hosted on clinicaltrials.gov verifies that this medical study, which originated on December 1st 2019, is actively searching for participants. Approximately 30 individuals must be enrolled from two different healthcare facilities."
Answered by AI
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