Alzheimer Disease study: Hearing Intervention
Official title Early Age-Related Hearing Loss Investigation (EARHLI)
ClinicalTrials.gov ID: NCT06174038
What this study is testing
- What it's testing
- The study aims to find out if a hearing intervention, including hearing aids, can reduce cognitive decline in people at risk for Alzheimer’s disease and related dementias.
- Who it's for
- Adults in late middle age who have hearing loss and are at risk for Alzheimer’s disease.
- What's involved
- Participants are randomly assigned to receive either a hearing aid intervention or a health‑education program, and they will undergo regular check‑ups and tests over the study period.
- Time commitment
- The study lasts about one year, with scheduled visits and assessments throughout that time.
- Time commitment: about 1 year
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 55 to 75
You may be able to join if
- Age 55-75 years of age
- Adult-onset hearing loss of approximately mild to moderate in severity (4-frequency 0.5, 1, 2, 4 kHz pure tone average 20 dB to 55 dB HL in better...
- Aidable hearing loss, defined by word recognition score in quiet ≥ 60% in better hearing ear
- Amnestic mild cognitive impairment (MCI) defined by Mini-Mental State Exam (MMSE2) score \>23, Clinical Dementia Rating (CDR) global score equivalent...
- Availability of a study partner (informant) for the administration of the cognitive screen and the ADCS-Activities of Daily Living-Prevention...
You likely can't join if
- Self-reported congenital hearing loss, known genetic mutation-related hearing loss, or hearing loss onset before middle age (\<45 years old)
- Prior dementia diagnosis
- Reported disability in ≥ 2 activities of daily living (ADLs)
- Current or previous consistent hearing aid user (such as utilization of hearing aids within the past 6 months beyond brief trials)
- Unwillingness to wear hearing aids regularly (≥8 hours/day)
- Medical contraindications to the use of hearing aids (e.g., actively draining ear)
See the full eligibility criteria
- Age 55-75 years of age
- Adult-onset hearing loss of approximately mild to moderate in severity (4-frequency 0.5, 1, 2, 4 kHz pure tone average 20 dB to 55 dB HL in better hearing ear)
- Aidable hearing loss, defined by word recognition score in quiet ≥ 60% in better hearing ear
- Amnestic mild cognitive impairment (MCI) defined by Mini-Mental State Exam (MMSE2) score \>23, Clinical Dementia Rating (CDR) global score equivalent = 0.5, and ADNI3 criteria of Logical Memory II score of ≤6 if 0-7...
- Availability of a study partner (informant) for the administration of the cognitive screen and the ADCS-Activities of Daily Living-Prevention Instrument (ADCS-ADL-PI)
- Community-dwelling
- Fluent in English or Spanish
- Availability of participant in area for study duration
- Self-reported congenital hearing loss, known genetic mutation-related hearing loss, or hearing loss onset before middle age (\<45 years old)
- Prior dementia diagnosis
- Reported disability in ≥ 2 activities of daily living (ADLs)
- Current or previous consistent hearing aid user (such as utilization of hearing aids within the past 6 months beyond brief trials)
- Unwillingness to wear hearing aids regularly (≥8 hours/day)
- Medical contraindications to the use of hearing aids (e.g., actively draining ear)
- Corrected vision impairment (worse than 20/63 on MNRead Acuity Chart in worse eye)
- Untreatable conductive hearing loss with air-bone gap \> 15 dB in two or more contiguous octave frequencies in both ears
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, 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 study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, 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.