Hearing Aids + Health Education for Age-Related Hearing Loss

(EARHLI Trial)

Overseen By Larry Tapia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Congenital hearing loss, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether hearing aids or health education can reduce cognitive decline in individuals at risk for Alzheimer's disease. Participants will either receive hearing aids with follow-up sessions or join a health education program on healthy aging. The goal is to determine if improving hearing can also enhance memory and thinking skills. The trial seeks individuals aged 55-75 with mild to moderate hearing loss and some memory issues, but without a dementia diagnosis. Participants must be willing to wear hearing aids regularly and should not have used them consistently in the past. As an unphased trial, this study offers a unique opportunity to contribute to understanding how hearing improvement might protect against cognitive decline.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that hearing aids are generally safe for older adults. Studies have found that these devices can improve quality of life and assist with hearing difficulties. Available studies have reported no major harmful effects directly linked to hearing aid use.

Some individuals might need time to adjust to wearing hearing aids and may experience mixed results in determining sound direction. However, these are not dangerous side effects; they are simply part of the adjustment process.

Overall, hearing aids are considered safe and well-tolerated for most people. For those considering joining a trial involving hearing aids, this evidence suggests they are unlikely to cause harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a comprehensive approach to managing age-related hearing loss by combining hearing aids with health education. Unlike typical treatments focused solely on hearing aids, this trial includes a health education program about healthy aging, which may enhance overall well-being and adherence to using hearing aids. The dual approach could lead to better outcomes by addressing both the physical and lifestyle aspects of hearing loss. This could pave the way for more holistic treatment strategies that improve both hearing and quality of life for older adults.

What evidence suggests that this trial's treatments could be effective for age-related hearing loss?

Research has shown that hearing aids, which participants in this trial may receive as part of the Hearing Intervention arm, can greatly enhance life for older adults with hearing loss. Studies indicate that hearing aids help people hear better and feel less troubled by their hearing issues. Some studies also suggest that hearing aids might reduce the risk of developing dementia. While the ability to localize sound might vary, the overall benefits of hearing aids are well-supported. Therefore, hearing aids could help slow mental decline linked to age-related hearing loss. ^{2 3 4 6 7}

Who Is on the Research Team?

Justin S Golub, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Aidable hearing loss, defined by word recognition score in quiet ≥ 60% in better hearing ear

I have someone who can help with my study-related assessments.

I am between 55 and 75 years old.

Exclusion Criteria

Current or previous consistent hearing aid user (such as utilization of hearing aids within the past 6 months beyond brief trials)

Unwillingness to wear hearing aids regularly (≥8 hours/day)

Medical contraindications to the use of hearing aids (e.g., actively draining ear)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either a hearing intervention or a health education intervention. The hearing intervention includes 4 sessions across 8 weeks with a booster session and hearing aid fitting.

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for cognitive decline, social engagement, and changes in brain organization/connectivity. Assessments occur at study start, 6 months, and 12 months.

1 year

3 visits (in-person)

Extension

Participants in the health education group receive hearing aids at the end of their 12-month participation.

End of study

What Are the Treatments Tested in This Trial?

Interventions

• Health Education Intervention
• Hearing Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Hearing Intervention Experimental Treatment 1 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 Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

A randomized controlled trial showed that first-time hearing aid users who received an educational intervention using reusable learning objects (RLOs) had significantly better knowledge about hearing aids and communication compared to a control group.

The improvement in knowledge was clinically significant, with moderate to large effect sizes, indicating that such educational interventions can effectively enhance understanding and potentially improve the user experience with hearing aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information Retention and Overload in First-Time Hearing Aid Users: An Interactive Multimedia Educational Solution. Ferguson, M., Brandreth, M., Brassington, W., et al.[2022]

The 'Drugs' workshop in a cardiac rehabilitation program significantly improved patients' knowledge about medication, with average scores increasing from 4.46/10 before the workshop to 7.98/10 immediately after, and 7.53/10 at a follow-up, indicating lasting benefits.

The improvement in knowledge was consistent across different patient profiles, with 93.5% of participants showing better scores at follow-up, highlighting the effectiveness of the workshop in educating patients about their medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Education program for cardiac rehabilitation: Impact of the "Drugs" multidisciplinary workshop on the patients' knowledge in the short- and long-term]. Laloi, L., Leromain, AS., Jarre, C., et al.[2021]

Health education aims to improve health outcomes by focusing on changing specific health behaviors that impact health promotion and disease prevention, making it essential for educational interventions.

Effective health education is a structured process that requires understanding communication strategies and should be integrated with broader public health programs to maximize its impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Health education. Educational approach to change]. van Parijs, LG.[2019]

Patient education significantly improves compliance with therapeutic regimens in chronic disease management, with an average improvement of 0.67 sigma over control groups, indicating a strong effect.

While patient education also leads to improvements in physiological progress (0.49 sigma) and health outcomes (0.02 sigma), the most effective strategies involve behaviorally-oriented programs that focus on changing the patient's environment rather than just increasing knowledge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does patient education in chronic disease have therapeutic value? Mazzuca, SA.[2019]

A study involving 139 older audiological patients showed that home-fitting of hearing aids, especially when supported by geriatric nursing assistants, improved patient satisfaction and usage compared to conventional fitting methods.

Collaboration between audiology and geriatric departments, along with home services, was found to be effective in enhancing hearing aid use and patient support, suggesting that integrated care models can significantly benefit older adults with hearing impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hearing in a geriatric perspective]. Boisen, G., Lindemann, L., Lange, K., et al.[2015]

Recent advancements in the design and functionality of wearable hearing aids have significantly increased their effectiveness, allowing more people with hearing impairments to benefit from them.

Current guidelines for recommending hearing aids are outdated; now, individuals with any level of permanent hearing loss should be considered for aural rehabilitation and the use of hearing aids, regardless of their previous prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The successful hearing aid user. Sanders, JW.[2000]

A study involving 209 older adults developed health promotion materials about alcohol use, showing that education can significantly increase knowledge and self-efficacy regarding alcohol's effects on health and medication use.

Over 45% of participants engaged with the materials independently, indicating that older adults are interested in learning about alcohol-related health issues, which suggests the importance of including their input in creating educational resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informing older adults about non-hazardous, hazardous, and harmful alcohol use. Fink, A., Beck, JC., Wittrock, MC.[2019]

Only 5.8% of independently living older adults aged 55-79 expressed interest in a peer-led health education course, with the highest interest found among females aged 55-64, unmarried individuals, and those with low wellbeing.

Despite low overall interest, those who subscribed to the course were more likely to be from lower socio-economic backgrounds, have reduced wellbeing, physical limitations, and poor self-efficacy, indicating a need for targeted outreach to these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interest in participation in a peer-led senior health education program. Kocken, PL., Voorham, AJ.[2019]

In a study involving 63 older adults with hearing impairment, those who received treatment showed a significant but weak decrease in daily hearing aid use after the intervention.

The findings suggest that the amount of hearing aid use may not be a reliable indicator of rehabilitation success, highlighting the need for further exploration of effective measures in hearing aid rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased use of hearing aids following training in hearing tactics. Andersson, G.[2018]

The multimedia educational program (C2Hear reusable learning objects) significantly improved self-efficacy and knowledge about hearing aids in first-time users compared to a printed booklet, based on a study of 56 adults.

Participants who received the RLOs also showed a borderline increase in readiness for hearing rehabilitation, suggesting that this educational approach can help users better manage their hearing aids before they start using them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving self-efficacy for hearing aid self-management: the early delivery of a multimedia-based education programme in first-time hearing aid users. Gomez, R., Ferguson, M.[2021]

The 'Keep on Talking' program significantly improved communication knowledge and skills among older adults, with 45% of participants taking action to enhance their communication abilities after one year, compared to only 10% in the control group.

Communication education programs, like 'Active Communication Education,' are valuable supplements to traditional hearing aid fittings, helping older adults develop practical strategies for better communication in daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond hearing aid fitting: improving communication for older adults. Hickson, L., Worrall, L.[2015]

The Active Communication Education (ACE) program, designed for older adults with hearing loss, was evaluated in a pilot study with 29 participants aged 87 in Sweden, where 79% completed the program.

Although the effect size of the ACE program was small and not statistically significant, 90% of participants reported that it helped them better manage their hearing loss, indicating potential benefits that warrant further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary evaluation of the active communication education program in a sample of 87-year-old hearing impaired individuals. Oberg, M., Bohn, T., Larsson, U., et al.[2020]

The m2Hear mobile health educational intervention was positively received by 16 first-time hearing aid users over a 10-week trial, enhancing their capability to understand and use hearing aids effectively.

Participants reported that m2Hear improved their confidence and self-management of hearing loss, demonstrating the effectiveness of combining theoretical models with practical resources in mHealth education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a Theoretically Informed and Cocreated Mobile Health Educational Intervention for First-Time Hearing Aid Users: Qualitative Interview Study. Maidment, DW., Heyes, R., Gomez, R., et al.[2021]

Auditory rehabilitation programs, particularly group programs like 'Active Communication Education,' have been shown to effectively improve communication strategies and social participation in older adults with hearing loss.

The combination of hearing aid fitting and communicative programs significantly enhances the quality of life for patients with hearing loss by reducing activity limitations and promoting social engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Auditory rehabilitation programmes for adults: what do we know about their effectiveness?]. Cardemil, F., Aguayo, L., Fuente, A.[2014]

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]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK616586/

Outcomes for Hearing Health Interventions - NCBI - NIH Sound localization tests in hearing aid wearers have shown mixed results, with some studies showing poorer performance among hearing aid wearers than among ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11532099/

Impact of hearing rehabilitation programs on presbycusis ... The meta-analysis reveals a statistically significant enhancement in hearing aid efficacy, a reduction in self-reported hearing impairment, and ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2826555

A Hearing Intervention and Health-Related Quality of Life ... Treatment of hearing loss could potentially improve health-related quality of life among older adults with hearing loss. The effect of hearing ...

4. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-021-02033-z

Evaluation of the efficacy of hearing aids in older adults This study aims to show the potential positive effect of HAs on auditory skills and on quality of life of older adults with hearing loss. In ...

5. academic.oup.com academic.oup.com/aje/article/194/10/2844/7924558

hypothetical intervention on the use of hearing aids for the risk ... Observational studies have reported that hearing aid (HA) use is associated with a reduced risk of dementia diagnosis, suggesting a possible ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02448706

Variability In Hearing Aid Outcomes In Older Adults ... We anticipate that the outcome of this work will be a battery of assessments that will guide hearing aid processing for older patients with hearing loss.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0020748925000598

Effects on health outcomes following a nurse-led hearing ... 1.1.​​ This study aimed to examine the effects of a nurse-led hearing loss management intervention designed for older adults on five outcomes shown to be ...