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Behavioural Intervention

Hearing Aids + Health Education for Age-Related Hearing Loss (EARHLI Trial)

N/A

Recruiting

Led By Justin S Golub, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Self-reported congenital hearing loss, known genetic mutation-related hearing loss, or hearing loss onset before middle age (<45 years old)

Reported disability in ≥ 2 activities of daily living (ADLs)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0, week 28, week 52

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore how hearing aids & health ed. can reduce cognitive decline associated with AD/ADRD in late middle age adults. Participants will be followed for 1 year.

Who is the study for?

The EARHLI trial is for late middle-aged adults who are experiencing early age-related hearing loss and may be at risk for cognitive decline or Alzheimer's Disease. Participants will be followed for a year to see if interventions help.

What is being tested?

This study tests whether providing hearing aids (hearing intervention) can reduce cognitive decline compared to just receiving health education. Adults in the trial will receive one of these two interventions randomly.

What are the potential side effects?

Hearing aids might cause minor discomfort, irritation, or feedback noise when used improperly. Health education has no direct side effects but lacks the potential direct benefits of improved hearing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 55 and 75 years old.

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I have mild to moderate hearing loss as an adult.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have hearing loss from birth, due to genetics, or it started before I was 45.

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I need help with two or more daily activities like eating or dressing.

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I have hearing loss that cannot be treated, affecting both ears.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0, week 28, week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0, week 28, week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 28, week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Brain MRI Measures

+9 more

Other study objectives

CESD-12 Depression (CES) Score

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

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

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Hearing InterventionExperimental Treatment1 Intervention

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

Group II: Health Education InterventionExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Health Education Intervention

2016

N/A

~1930

0 / 5Eligibility criteria met