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Behavioural Intervention

Health Education Intervention for 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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0, week 28, week 52

Awards & highlights

EARHLI Trial 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.Check my eligibility

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.See study design

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.

EARHLI Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 55 and 75 years old.

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I have mild to moderate hearing loss as an adult.

EARHLI Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

EARHLI 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,447,109 Total Patients Enrolled

1 Trials studying Hearing Loss

20 Patients Enrolled for Hearing Loss

University of WashingtonOTHER

1,741 Previous Clinical Trials

1,847,610 Total Patients Enrolled

2 Trials studying Hearing Loss

697 Patients Enrolled for Hearing Loss

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,735 Total Patients Enrolled

8 Trials studying Hearing Loss

2,652 Patients Enrolled for Hearing Loss

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction to participate in this medical experiment?

"This trial has restricted its applicant pool to those between 55 and 75 years of age. Alternatively, there are 82 trials for minors and 810 clinical studies open to elderly people."

Answered by AI

How many participants are presently taking part in this experiment?

"That is correct. According to information found on clinicaltrials.gov, this trial was initially launched on January 15th 2024 and has been actively seeking participants since then. The study requires 150 patients from 1 medical centre to complete their research."

Answered by AI

What are the criteria for eligibility into this medical study?

"This trial is searching for 150 subjects with hearing loss aged between 55 and 75. Qualifying candidates have a chance to participate in the study."

Answered by AI

Are there any vacancies remaining for individuals to join this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this study is actively enrolling participants and has been since its initial posting of January 15th 2024. As of December 8th 2023, there are 150 spots available at one research site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Justin S. Golub 2024. "Early Age-Related Hearing Loss Investigation (EARHLI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06174038.

All > Alzheimers Disease New York > Hearing Loss