Early Age-Related Hearing Loss Investigation (EARHLI)

Study Overview
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Brief Summary
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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).

Detailed Description
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EARHLI will be a phase II 1:1 randomized controlled trial of a hearing intervention (including prescription hearing aids) versus a health education program. Participants must be 55-75 years old and have early-stage age-related hearing loss and amnestic mild cognitive impairment. The trial will last 1 year and occur at a single site (Columbia University Irving Medical Center). Outcome measurements will include cognition, social engagement, and change in brain organization/connectivity. Assessments will occur at study start, 6 months, and 12 months. A total of 150 participants will be enrolled (75 per intervention group). Participants will also have a hearing test and a blood test. Approximately half of participants will have two MRI scans. As part of participating, all participants will get prescription hearing aids, either at study start or end.

Official Title
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Early Age-Related Hearing Loss Investigation (EARHLI): A Randomized Controlled Trial to Assess the Mechanisms Linking Early Age-Related Hearing Loss and Alzheimer's Disease and Related Dementias

Conditions
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Alzheimer Disease, Hearing Loss, Cognitive Impairment

Intervention / Treatment
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* Device: Hearing Intervention
* Behavioral: Health Education Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion 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 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hearing Intervention<br>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<br>* 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.<br>|
| Other: Health Education Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hearing Loss, Alzheimer's, Alzheimer, Hearing Aid, Memory Loss, Memory, Audiogram, Cognition