Hearing Loss study: Over the counter hearing aid
Official title OTC Hearing Aid and MCI
ClinicalTrials.gov ID: NCT06112860
What this study is testing
- What it's testing
- The study wants to see if OTC hearing aids help communication for people with hearing loss and mild cognitive problems, and whether the benefit changes with cognitive level. It also compares these aids to special communication strategies.
- Who it's for
- Adults who have mild to moderate hearing loss and mild cognitive impairment or early Alzheimer‑related dementia.
- What's involved
- Participants and a communication partner will be randomly assigned to receive either an OTC hearing aid first or a set of communication‑strategy instructions first. They will use the assigned tool and complete study visits and questionnaires.
- Time commitment
- The study lasts for several months with multiple visits to receive the device or strategy training and to complete follow‑up assessments.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 90
You may be able to join if
- Over 60 years of age
- Mild dementia or mild cognitive impairment. Diagnosis will be made at participating memory evaluation centers (see recruitment).
- Mild to moderate bilateral hearing loss and no current hearing aid use.
- A communication partner who is able and willing to participate in the study.
- No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration)
You likely can't join if
- Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant...
- History of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder...
- Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
- Co-enrolled in other intervention studies targeting hearing, language, or communication strategies.
- History or current fluctuating hearing loss
See the full eligibility criteria
- Over 60 years of age
- Mild dementia or mild cognitive impairment. Diagnosis will be made at participating memory evaluation centers (see recruitment).
- Mild to moderate bilateral hearing loss and no current hearing aid use.
- A communication partner who is able and willing to participate in the study.
- No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration)
- Able to provide own consent as evaluated by the Consent Assessment
- Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study.
- History of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down's syndrome), or head/neck cancer
- Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
- Co-enrolled in other intervention studies targeting hearing, language, or communication strategies.
- History or current fluctuating hearing loss
The study team makes the final eligibility decision.
Where it is enrolling
- Evanston, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Evanston, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.