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Hearing Aid Intervention for Cognitive Decline (ACHIEVE-BHFU Trial)
ACHIEVE-BHFU Trial Summary
This trial will help researchers understand if hearing aid intervention can help prevent cognitive decline in older adults.
ACHIEVE-BHFU Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowACHIEVE-BHFU Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ACHIEVE-BHFU Trial Design
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Who is running the clinical trial?
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- You need to score 23 or higher on a test to join the study if you have a high school degree or less, and 25 or higher if you have some college education or more.You have moderate to severe hearing loss in your better ear.It seems like "Original ACHIEVE" might be a specific term or acronym related to a clinical trial. Without additional context, it's difficult to provide a plain language summary. If you could provide more information or clarify, I'd be happy to help summarize it for you!I am between 70 and 84 years old.You have used a hearing aid in the past year.I cannot use hearing aids due to a medical issue like a draining ear.I am not willing to wear hearing aids every day.You are allowed to take part in the ACHIEVE trial.You can understand and repeat words correctly most of the time, even in a quiet environment.I am between 70 and 84 years old.Your vision is worse than 20/63 on a specific vision test.You have moderate to severe hearing loss in both ears, measured at specific frequencies.I need help with two or more daily activities like eating or dressing.I have hearing loss where sounds don't travel well to my inner ear in both ears.
- Group 1: Hearing intervention (HI) group
- Group 2: Successful aging/Delayed hearing intervention (SA/DHI) group
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is this research looking for more participants?
"Unfortunately, this particular trial is not accepting any more participants at this time. The trial was posted on November 7th, 2022 and updated on October 7th, 2022. Although this trial might not be right for you, there are 1263 other trials that might be a better fit."
Would I be a good candidate for this research project?
"This medical trial is enrolling 859 individuals, all of whom are over the age of 73 and suffer from dementia. Furthermore, it is crucial that participants meet the following additional requirements: Be willing and able to comply with study procedures for a three-year period, Be between the ages of 70 and 84, Be a community dwelling individual, Be a fluent English speaker, Be available in the area for the duration of the study, Have adult-onset hearing impairment (as defined by a four-frequency pure tone average (PTA) of 0.5-4 kHz that is no worse than 70 dB HL in the better"
In how many different medical facilities is this medical study taking place?
"At the moment, this study is focusing on enrolling patients at Johns Hopkins Comstock Center for Public Health Research and Prevention in Hagerstown, Maryland, University of Minnesota in Minneapolis, Minnesota, and University of Mississippi Medical Center in Jackson, Mississippi. There are 4 other potential sites for recruitment."
If an older person wanted to participate in this research, would they be allowed to?
"Out of the 1185 clinical trials currently taking place, 96 are for minors and this particular one is for elderly patients aged 73 to 89."
Could you please clarify the risks associated with the Hearing intervention (HI) group?
"The team at Power has HI group's safety at a 3 because it is a Phase 3 trial. This suggests that there is data affirming HI group's efficacy as well as multiple rounds of data that support HI group's safety."
What do researchers hope to learn from this clinical trial?
"The goal of this trial is to study the effects of the medication on mild cognitive impairment (MCI) / dementia, over a period of 6 years. Secondary outcomes that will be measured include change in regional brain volumes, change in cognition in the memory domain, and change in cognition in the language domain."
Who else is applying?
What portion of applicants met pre-screening criteria?
What state do they live in?
How many prior treatments have patients received?
What site did they apply to?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Wake Forest University: < 24 hours
Average response time
- < 1 Day
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