Early Age-Related Hearing Loss Investigation (EARHLI)

NCT06174038 | Recruiting FDA Device

• 2 other identifiers: AAAU1896R01AG075083
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Early Age-Related Hearing Loss Investigation (EARHLI) is a single site study that will randomize late middle age adults to either a hearing intervention (including hearing aids) or a health education intervention. Participants will be followed for 1 year. This study will provide information on reducing cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD).

Conditions

Alzheimer Disease; Hearing Loss; Cognitive Impairment

Keywords

Hearing Loss; Alzheimer's; Alzheimer; Hearing Aid; Memory Loss; Memory; Audiogram; Cognition

Outcome Measures

Primary Outcomes (12)

• Free and Cued Selective Reminding Test (FC-SRT) Score

  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.

  Week 0, Week 28, Week 52

• Delayed Recall Log Memory IIa, (DRLM) Score

  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.

  Week 0, Week 28, Week 52

• Digit Symbol Substitution Test, (DSST) Score

  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.

  Week 0, Week 28, Week 52

• Mini-Mental State Examination 2, (MMSE-2) Score

  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.

  Week 0, Week 28, Week 52

• Trail Making Test Part B, (TMTB) Score

  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.

  Week 0, Week 28, Week 52

• Activities of Daily Living for Mild Cognitive Impairment, (ADCS-ADLPI) Score

  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

  Week 0, Week 28, Week 52

• Social Activity Frequency

  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

  Week 0, Week 28, Week 52

• Ability to Participate in Social Roles and Activities (APSR) Score

  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.

  Week 0, Week 28, Week 52

• Community Integration Measure (CIM) Score

  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.

  Week 0, Week 28, Week 52

• Cohens Social Network Index (SNI) Score

  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.

  Week 0, Week 28, Week 52

• University of California Loneliness Scale (ULS) Score

  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.

  Week 0, Week 28, Week 52

• Brain MRI Measures

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

  Week 0, Week 52

Other Outcomes (8)

• Hearing Handicap Index for Adults and the Elderly-Short (HHIS) Score

  Week 0, Week 28, Week 52

• Hearing Handicap Index-Short-Significant Other (HHIO) Score

  Week 0, Week 28, Week 52

• Speech, Spatial and Qualities of Hearing Scale (SSQ12) Score

  Week 0, Week 28, Week 52

Study Arms (2)

Hearing Intervention

OTHER

Participants will receive 4 sessions across 8 weeks with a later booster session and hearing aid fitting. Each session will take \~75 minutes.

Device: Hearing Intervention

Health Education Intervention

OTHER

Participants will receive a modified health education program on healthy aging. It will match the number and length of sessions as the hearing intervention, including compliance/phone checks. Participants will be on a waitlist to obtain hearing aids without fee at the end of their 12-month participation.

Behavioral: Health Education Intervention

Interventions

Hearing Intervention DEVICE

The hearing intervention includes an auditory needs assessment, hearing aid fitting, establishing Bluetooth connectivity from hearing aids to devices such as smartphones and computers, systematic orientation and instruction in device use, and provision and discussion of hearing "toolkit" materials for self-management and communication strategies. The hearing intervention is person-centered, focusing on identification of individual needs, setting of specific goals, engagement in shared-informed decision-making, and development of self-management abilities. Intervention-centric outcomes (e.g., hearing aid data logging, real ear measures) to verify the best-practices intervention will be gathered at all 5 intervention sessions as well as weeks 16 and 52. Additional visits to troubleshoot hearing aids or address concerns will be scheduled as needed.

Hearing Intervention

Health Education Intervention BEHAVIORAL

The evidence-based interactive health education program is designed for older adults and addresses chronic disease and disability prevention. Session content will be individualized for each participant based on a "key," depending on his/her goals/interests. The curriculum includes didactics, activities, and goal setting led by staff trained/certified to deliver the intervention.

Health Education Intervention

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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)
• 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

Sponsors & Collaborators

• Columbia University: lead
• Johns Hopkins University: collaborator
• National Institute on Aging (NIA): collaborator
• University of South Florida: collaborator
• University of Pittsburgh: collaborator
• University of Washington: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Related Publications (1)

• Denham MW, Arnold ML, Sanchez VA, Lin FR, Tucker LH, Gomez MC, Fernandez K, Arpi P, Neil H, Boyle S, Selevan S, Sussman TJ, Gmelin T, Fine I, Glynn NW, Teresi J, Noble JM, Goldberg T, Luchsinger JA, Golub JS. Design and Methods of the Early Age-Related Hearing Loss Investigation Randomized Controlled Trial. Otol Neurotol. 2024 Jun 1;45(5):594-601. doi: 10.1097/MAO.0000000000004093.

  PMID: 38728564 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Hearing Loss; Cognitive Dysfunction; Memory Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurobehavioral Manifestations

Study Officials

• Justin S Golub, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larry Tapia

CONTACT

646-317-3252; earhli@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Otolaryngology/Head and Neck Surgery

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

US (1)