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Procedure
Hearing Rehabilitation for Cognitive Impairment
N/A
Recruiting
Led By Esther Oh, MD, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of probable Alzheimer's Disease or other related dementia according to the core clinical criteria outlined in the National Institute on Aging (NIA) and Alzheimer's Association Guidelines
Age 60 - 100 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 1 month post-intervention (immediate group). 1 month post-baseline (delayed group)
Summary
This trial aims to develop and test a hearing rehabilitation program that will be delivered by a speech-language pathologist to individuals with cognitive impairment. The program is designed to be affordable and easily accessible.
Who is the study for?
This trial is for English-speaking individuals aged 60-100 with probable Alzheimer's or related dementia, who live at home and have stable medication dosing. They must have adult-onset hearing loss and a caregiver available to assist with the study.
What is being tested?
The HEARS-SLP program and device are being tested to see if they can help people with cognitive impairment by providing affordable hearing care through speech-language pathologists.
What are the potential side effects?
Since this trial involves a non-invasive intervention focused on hearing health care, side effects may be minimal but could include discomfort from using the HEARS-SLP device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Alzheimer's Disease or a similar type of dementia.
Select...
I am between 60 and 100 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 1 month post-intervention (immediate group). 1 month post-baseline (delayed group)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 1 month post-intervention (immediate group). 1 month post-baseline (delayed group)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Neuropsychiatric Symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q)
Secondary study objectives
Change From Baseline in Hearing Specific Quality of life as assessed by the Hearing Handicap Inventory for the Elderly (HHIE-S)
Change from Baseline in Health-related Quality of Life as assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) scale
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Immediate treatmentExperimental Treatment2 Interventions
immediate treatment
Group II: Delayed treatmentPlacebo Group2 Interventions
1 month delayed treatment
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,788 Previous Clinical Trials
28,184,493 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,769 Total Patients Enrolled
Esther Oh, MD, PhDPrincipal InvestigatorJohns Hopkins School of Medicine
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