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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 belowSelect...
I am between 55 and 75 years old.
Select...
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:Select...
I have hearing loss from birth, due to genetics, or it started before I was 45.
Select...
I need help with two or more daily activities like eating or dressing.
Select...
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
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 moreOther 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 moreAwards & 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
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,498 Previous Clinical Trials
2,766,975 Total Patients Enrolled
University of WashingtonOTHER
1,829 Previous Clinical Trials
1,906,944 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,802 Previous Clinical Trials
28,193,831 Total Patients Enrolled
University of South FloridaOTHER
427 Previous Clinical Trials
192,481 Total Patients Enrolled
University of PittsburghOTHER
1,792 Previous Clinical Trials
16,359,836 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,339 Previous Clinical Trials
14,881,616 Total Patients Enrolled
Justin S Golub, MDPrincipal InvestigatorColumbia University