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Audiology Services via Telehealth for Hearing Loss in Aging

N/A
Waitlist Available
Led By Frank R Lin, MD, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have been eligible for and participated in the hearing intervention arm of the ACHIEVE trial
Participants must agree to be randomized to receive continued hearing care via either a telehealth or conventional delivery model
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether a telehealth hearing healthcare model is better than the conventional clinic-based model in improving hearing aid use and communication outcomes in older adults.

Who is the study for?
This trial is for older adults aged 70-84 with adult-onset hearing loss who previously participated in the ACHIEVE trial. They must have a mild to moderate hearing impairment and be open to using telehealth or clinic-based hearing care. Exclusions include severe vision impairment, recent use of hearing aids, unwillingness to wear them daily, certain ear conditions, and significant disability in daily activities.Check my eligibility
What is being tested?
The study compares two ways of delivering hearing healthcare: traditional in-clinic visits versus telehealth services. It aims to see if telehealth can improve how often older adults use their hearing aids and other communication outcomes compared to standard clinic visits.See study design
What are the potential side effects?
Since this trial involves service delivery methods rather than medications, there are no direct side effects like those associated with drugs. However, participants may experience differences in satisfaction or effectiveness between the two models.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was part of the hearing intervention in the ACHIEVE trial.
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I agree to possibly receive hearing care online or in person.
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I am between 70 and 84 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average daily hours of hearing aid use
Secondary outcome measures
Ability to hear for primary communication goal as assessed by a single item from the Client-Oriented Scale of Improvement (COSI) goals achievement questionnaire
Hearing-specific quality of life as assessed by the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S) questionnaire
Treatment satisfaction as assessed by a single item from the International Outcome Inventory - Comprehensive Hearing Intervention (IOI-CHI) scale

Trial Design

2Treatment groups
Experimental Treatment
Group I: Telehealth hearing healthcare groupExperimental Treatment1 Intervention
The telehealth hearing healthcare group will have clinic-based visits every 6 months for the duration of the 2-year study. This group will receive telehealth audiological rehabilitative service delivery and be able to utilize telehealth options, in addition to conventional options, to address any unanticipated needs that arise during both years of the study.
Group II: Conventional hearing healthcare groupExperimental Treatment2 Interventions
The conventional hearing healthcare group will have clinic-based visits every 6 months for the duration of the 2-year study. During Year 1, this group will receive clinic-based audiological rehabilitative service delivery and be able to use conventional options to address any unanticipated needs that arise, and then during Year 2, this group will also receive telehealth audiological rehabilitative service delivery and be able to utilize telehealth options, in addition to conventional options, to address any unanticipated needs that arise.

Find a Location

Who is running the clinical trial?

Wake Forest UniversityOTHER
187 Previous Clinical Trials
153,184 Total Patients Enrolled
1 Trials studying Hearing Loss
859 Patients Enrolled for Hearing Loss
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
325 Previous Clinical Trials
177,821 Total Patients Enrolled
54 Trials studying Hearing Loss
19,611 Patients Enrolled for Hearing Loss
Johns Hopkins UniversityLead Sponsor
2,242 Previous Clinical Trials
14,816,298 Total Patients Enrolled
12 Trials studying Hearing Loss
4,536 Patients Enrolled for Hearing Loss

Media Library

Clinic-based audiological rehabilitative service delivery Clinical Trial Eligibility Overview. Trial Name: NCT05070429 — N/A
Hearing Loss Research Study Groups: Conventional hearing healthcare group, Telehealth hearing healthcare group
Hearing Loss Clinical Trial 2023: Clinic-based audiological rehabilitative service delivery Highlights & Side Effects. Trial Name: NCT05070429 — N/A
Clinic-based audiological rehabilitative service delivery 2023 Treatment Timeline for Medical Study. Trial Name: NCT05070429 — N/A
Hearing Loss Patient Testimony for trial: Trial Name: NCT05070429 — N/A

Frequently Asked Questions

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

Are recruitment efforts underway for participants in this investigation?

"The aforementioned clinical trial, first posted on November 12th 2021, is not actively seeking patients as of August 9th 2022. However, there are an abundance of other medical studies which are currently recruiting participants."

Answered by AI

Does this medical trial encompass geriatric participants?

"Within the bounds of this medical trial's inclusion criteria, elderly persons aged 73 to 88 are eligible for enrollment."

Answered by AI

Is it possible to partake in this clinical experimentation?

"Eligibility for this trial necessitates that applicants suffer from hearing impairment and are aged between 73 and 88. This clinical study is aiming to recruit a total of 490 individuals."

Answered by AI

In how many distinct venues is this trial conducted?

"This trial is recruiting from a number of medical centres, such as Wake Forest University in Winston-Salem, North carolina; Johns Hopkins Comstock Center for Public Health Research and Prevention in Hagerstown, Maryland; and University of Minnesota at Minneapolis. Additionally there are 4 additional sites that are being used to enrol patients."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
North Carolina
How old are they?
18 - 65
What site did they apply to?
University of Minnesota
Wake Forest University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have tinnitus and Now am 64 and my hearing is not getting better. I have battled with tinnitus and some hearing loss for about 10 years. I have tried over the counter meds, sound therapy and other treatments to no avail. I would like to be a part of this trial to hopefully find some relief from my condition.
PatientReceived 2+ prior treatments
~102 spots leftby Mar 2025