K-HEARS Interventions for Age-Related Hearing Loss

(K-HEARS Trial)

Overseen By Carrie L Nieman, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Current hearing aid use, Terminal illness, Others

Compensation: Varies

Number of Visits: Unknown

800 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this study is to test the effect of a community-delivered, affordable, and accessible hearing care intervention on improving communication function and health-related quality of life among older Korean Americans (KA) and the older Korean American's care partners that integrates a low-cost over-the-counter amplification device and hearing rehabilitation in comparison to a 6-month delayed treatment group through a cluster randomized controlled study.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the K-HEARS Interventions for Age-Related Hearing Loss treatment?

Research shows that hearing aids can improve satisfaction and daily use among older adults, as seen in studies where participants increased their hearing aid use and reported higher satisfaction after interventions. This suggests that similar treatments like K-HEARS could also help improve hearing and quality of life for those with age-related hearing loss. ^{1 2 3 4 5}

How is the K-HEARS treatment different from other treatments for age-related hearing loss?

The K-HEARS treatment is unique because it combines a specific intervention with a sound amplifier, potentially offering a more tailored approach to improving hearing in older adults compared to standard hearing aids or cochlear implants. This approach may address both the amplification of sound and the specific needs of individuals with age-related hearing loss, which is often not fully addressed by traditional methods. ^{1 3 6 7 8}

Research Team

Hae-Ra Han, PhD,RN

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for older Korean Americans and their care partners who are experiencing age-related hearing loss. Participants should be community-dwelling seniors interested in improving communication function and quality of life through a new hearing intervention.

Inclusion Criteria

Self-identified as first-generation KA in the target region

I have someone who lives with me or sees me weekly to help communicate.

Screening audiometry Pure-tone audiometry (PTA) 1,2,4 kilohertz (kHz) >25 decibel (dB) hearing loss (HL) in better ear

Exclusion Criteria

Current use of hearing aid

Medical contraindications to use amplification device (e.g., draining ear)

Plan to move from the area within 6 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Treatment

Participants receive the K-HEARS intervention immediately, which includes a low-cost over-the-counter amplification device and hearing rehabilitation

6 months

Regular community visits

Delayed Treatment

Participants receive the K-HEARS intervention after a 6-month delay, which includes a low-cost over-the-counter amplification device and hearing rehabilitation

6 months

Regular community visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• K-HEARS Intervention
• K-HEARS Sound Amplifier Intervention

Trial Overview The study tests the 'K-HEARS Intervention,' which includes an affordable over-the-counter sound amplifier and hearing rehabilitation, against a delayed treatment group to see if it improves communication and life quality.

Participant Groups

Group I: Immediate Treatment Site Experimental Treatment 2 Interventions

Study site assigned to immediate treatment of K-HEARS intervention

Group II: Delayed Treatment Site Placebo Group 2 Interventions

Study site assigned to 6-month delayed treatment of K-HEARS intervention

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Findings from Research

The SMART study involves 145 participants aged 50 and older, assessing the impact of hearing aids and cochlear implants on various health outcomes related to hearing loss.

Participants with cochlear implants reported higher levels of loneliness and social isolation, as well as poorer hearing and communication abilities compared to those using hearing aids, highlighting the need for effective rehabilitative therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Studying Multiple Outcomes After Aural Rehabilitative Treatment Study: Study Design and Baseline Results. Li, L., Blake, C., Sung, Y., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Studying Multiple Outcomes After Aural Rehabilitative Treatment Study: Study Design and Baseline Results. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Patterns of Aided Loudness Growth in Experienced Adult Listeners with Early-Onset Severe-Profound Hearing Loss. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Assisting Older Persons With Adjusting to Hearing Aids. [2017]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Satisfaction with Hearing Aids among Aged Patients with Different Degrees of Hearing Loss and Length of Daily Use. [2020]

5. Brazil pubmed.ncbi.nlm.nih.gov

Results of auditory rehabilitation in elderly users of hearing aids evaluated by a dichotic test. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

[Presbycusis]. [2008]

7. Ireland pubmed.ncbi.nlm.nih.gov

Auditory deprivation and health in the elderly. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Age-related hearing loss: quality of care for quality of life. [2022]