Early Age-Related Hearing Loss Investigation (EARHLI) for Alzheimer's Disease and Cognitive Impairment

The EARHLI study is looking at whether a hearing intervention, which includes hearing aids, can help reduce cognitive decline in people at risk for Alzheimer's disease. You may be able to join if you are between 55 and 75 years old, have mild to moderate age-related hearing loss, and have amnestic mild cognitive impairment (a type of memory problem). The study compares a Hearing Intervention (with hearing aids and instruction) to a Health Education Intervention (a program about chronic disease prevention). Researchers will measure your memory and thinking skills over one year to see if either intervention makes a difference. The current recruitment status is unclear.

Study design
This is a Phase II randomized controlled trial involving 150 participants. Participants will be randomly assigned to either the hearing intervention or the health education intervention.
What's involved
You would participate for one year, with assessments at the start, 6 months, and 12 months. This includes hearing tests, blood tests, and potentially two MRI scans.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year after the study begins.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06174038

Early Age-Related Hearing Loss Investigation (EARHLI)

Recruiting
NAAges 55–75InterventionalTreatment
Columbia University
~150 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Hearing InterventionHealth Education Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Free and Cued Selective Reminding Test (FC-SRT) Score
Measured over Week 0, Week 28, Week 52
+11 more outcomes measured
Alzheimer Disease
Hearing Loss
Cognitive Impairment
1 sites across 1 states
New York1
  • Justin S Golub, MD · PRINCIPAL_INVESTIGATOR · Columbia University

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Eligibility criteria

Inclusion

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 years of education, ≤9 if 8-15 years, and ≤11 if ≥16 years
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

Exclusion

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
  • Free and Cued Selective Reminding Test (FC-SRT) ScoreWeek 0, Week 28, Week 52

    This is the Cognitive Performance Test # 1 ADCS-PACC 1: Evaluates Episodic Memory. Scoring from 0 - 48 and a higher score translates into a preserved function of the episodic memory.

  • Delayed Recall Log Memory IIa, (DRLM) ScoreWeek 0, Week 28, Week 52

    This is the Cognitive Performance Test # 2 ADCS-PACC 2: Evaluates Episodic Memory. Scoring from 0 - 25 and a higher score translates into a preserved function of the episodic memory.

  • Digit Symbol Substitution Test, (DSST) ScoreWeek 0, Week 28, Week 52

    This it the Cognitive Performance test # 3 ADCS-PACC 3: Evaluates speed of processing. Scoring from 0 - 91 and a higher score relates to better performance and speed of processing.

  • Mini-Mental State Examination 2, (MMSE-2) ScoreWeek 0, Week 28, Week 52

    This is the Cognitive Performance test # 4 ADCS-PACC 4: Evaluates Global Cognition. Scoring from 0 - 30 and a higher score relates to preserved Global Cognition.

  • Trail Making Test Part B, (TMTB) ScoreWeek 0, Week 28, Week 52

    This is the Cognitive Performance test # 5 Evaluates Episodic Memory. Scored in terms of the time, in seconds, required to complete the trail. 300 seconds = maximum amount of time. The less seconds it takes to complete the trail, the better performance/ episodic memory.

  • Activities of Daily Living for Mild Cognitive Impairment, (ADCS-ADLPI) ScoreWeek 0, Week 28, Week 52

    This is the Cognitive Performance test # 6: Evaluates the ability of patients to perform Activities of Daily Living. Section a. Scored from 0 - 45: Items 1 to 15. Higher score for each activity equals better performance. Section b. Scored from 0 - 5. Item 16 to 20. Higher score equals better performance

  • Social Activity FrequencyWeek 0, Week 28, Week 52

    This is the Social Engagement and Related Socialization test # 1: Evaluates frequency of social activity participation. Participants are asked on a 5-point scale how often during the past 6 months they engaged in 6 common activities involving socialization. A composite score is created

  • Ability to Participate in Social Roles and Activities (APSR) ScoreWeek 0, Week 28, Week 52

    This is the Social Engagement and Related Socialization test # 2: Evaluates Social Activity Participation. Scored from 8 - 40 a higher score translates into higher levels of social participation.

  • Community Integration Measure (CIM) ScoreWeek 0, Week 28, Week 52

    This is the Social Engagement and Related Socialization test # 3: Evaluates Community Integration/Participation. Scored from 10 - 50. Higher scores indicate higher levels of community integration and participation.

  • Cohens Social Network Index (SNI) ScoreWeek 0, Week 28, Week 52

    This is the Social Engagement and Related Socialization test # 4: Evaluates Social Relationships. Scored from 1 - 12. Higher score indicates a larger number of social roles in which the respondent has regular contact.

  • University of California Loneliness Scale (ULS) ScoreWeek 0, Week 28, Week 52

    This is the Social Engagement and Related Socialization test # 5: Evaluates Individuals perception of loneliness. The total score ranges from 20 - 80. Higher scores indicate higher loneliness.

  • Brain MRI MeasuresWeek 0, Week 52

    Approximately 50% of all participants (random selection) will have a functional brain MRI.