Hearing Aid Fitting for Alzheimer's Disease

Recruiting at 1 trial location

Overseen By Elizabeth Stangl, AuD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yu-Hsiang Wu

Disqualifiers: Non-native English speaker

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

17 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a pilot study with the aim of evaluating the feasibility of the procedures of a future clinical trial that will help determine the impacts of hearing aid interventions on older patients with Alzheimer's Disease and related dementias (ADRD). In this pilot study individuals with mild or moderate cognitive impairment, as well as their caregivers, will be recruited. Participants will be randomly assigned to three intervention groups: Audiologist-Based Intervention, Service-Only Group, and Device-Only Group. Outcome data will be collected on the how hearing loss and hearing aid impact their lives and caregiver burden 6-week post hearing aid intervention.

Do I have to stop taking my current medications for this trial?

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

What data supports the idea that Hearing Aid Fitting for Alzheimer's Disease is an effective treatment?

The available research shows that hearing aids can be effective for people with Alzheimer's Disease. One study found that using hearing aids for 6 to 12 months helped improve thinking skills in older patients with both Alzheimer's and hearing loss. Another study reported that hearing aids reduced problem behaviors identified by caregivers in patients with Alzheimer's. This suggests that hearing aids not only help with hearing but also improve communication and reduce issues related to behavior, making them a beneficial treatment for Alzheimer's patients. ^{1 2 3 4 5}

What safety data exists for hearing aids in Alzheimer's treatment?

The studies reviewed do not directly address safety data for hearing aids in Alzheimer's treatment. However, they suggest that hearing aids are generally well-tolerated by Alzheimer's patients, as evidenced by successful fitting and usage in studies. The research primarily focuses on the efficacy of hearing aids in reducing problem behaviors and improving cognitive status, rather than safety concerns. No adverse effects or safety issues are reported in the studies provided. ^{1 2 6 7 8}

Is using hearing aids a promising treatment for Alzheimer's patients?

Yes, hearing aids can be a promising treatment for Alzheimer's patients. They help improve speech understanding and communication, which can enhance the quality of life for elderly individuals with hearing loss. Advances in technology have made hearing aids more effective and accessible, making them a realistic option for many people. ^{6 9 10 11 12}

Research Team

Yu-Hsiang Wu, PhD

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for older adults with mild or moderate cognitive disorders like Alzheimer's, who also have adult-onset mild-to-moderate hearing loss and haven't used hearing aids before. Participants must speak English natively.

Inclusion Criteria

You have never used a hearing aid before.

I have adult-onset hearing loss that is not severe.

I have been diagnosed with mild or moderate Alzheimer's disease.

Exclusion Criteria

You do not speak English as your first language.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to three intervention groups: Audiologist-Based Intervention, Service-Only Group, and Device-Only Group. Hearing aid interventions are provided.

6 weeks

Multiple visits as per intervention group requirements

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcome data collected on hearing loss impact and caregiver burden.

6 weeks

Treatment Details

Interventions

• Hearing Aid

Trial Overview The study tests three ways of fitting hearing aids: by an audiologist, service-only without an audiologist's fine-tuning, and device-only without additional services. It aims to see how these affect the lives of patients with cognitive impairments and their caregivers after 6 weeks.

Participant Groups

Group I: Service-Only Experimental Treatment 1 Intervention

In this group, hearing aids that have minimum amplification will be fitted by audiologists.

Group II: Device-Only Experimental Treatment 1 Intervention

In this group, hearing aids will be provided with minimum services from audiologists.

Group III: Audiologist-Based Active Control 1 Intervention

In this group, the audiologist-based fitting will be used to provide hearing aids.

Hearing Aid is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hearing Aid for:

• Hearing Loss
• Age-related Hearing Loss
• Sensorineural Hearing Loss

Approved in European Union as Hearing Aid for:

• Hearing Loss
• Age-related Hearing Loss
• Sensorineural Hearing Loss

Approved in Canada as Hearing Aid for:

• Hearing Loss
• Age-related Hearing Loss
• Sensorineural Hearing Loss

Who Is Running the Clinical Trial?

Yu-Hsiang Wu

Lead Sponsor

Trials

4

Recruited

710+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Findings from Research

In a study involving 51 older patients with Alzheimer's disease and hearing loss, the use of hearing aids for 6 months did not show a significant cognitive benefit compared to a placebo, with similar cognitive decline observed in both groups.

After a secondary activation phase of hearing aids in the placebo group, no significant improvement in cognitive function was noted, indicating that hearing aids may not provide cognitive advantages in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Hearing Aids on the Cognitive Status of Patients with Alzheimer's Disease and Hearing Loss: A Multicenter Controlled Randomized Trial. Nguyen, MF., Bonnefoy, M., Adrait, A., et al.[2018]

This study highlights the often-overlooked issue of hearing impairment in Alzheimer's disease patients, showing that addressing hearing deficits can significantly reduce caregiver-reported problem behaviors related to communication.

In a small group of 8 participants, the use of hearing aids led to a notable reduction in problem behaviors, with participants wearing their devices for 5 to 15 hours daily, demonstrating both compliance and efficacy of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in caregiver-identified problem behaviors in patients with Alzheimer disease post-hearing-aid fitting. Palmer, CV., Adams, SW., Bourgeois, M., et al.[2019]

Adults with mild cognitive impairment or Alzheimer's disease face significant cognitive barriers that affect their ability to use hearing aids effectively, as revealed through interviews with 10 participants aged 75-86.

Despite recognizing the benefits of hearing aids, participants expressed ambivalence towards their use, indicating a need for targeted strategies to enhance hearing aid adoption and support in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of hearing aid use among patients with mild cognitive impairment and Alzheimer's disease dementia: A qualitative study. Gregory, S., Billings, J., Wilson, D., et al.[2022]

The study highlights that traditional clinical procedures for Alzheimer's Disease often overlook hearing issues, suggesting a need for innovative ways to measure treatment effectiveness, particularly through caregiver-reported behaviors.

Modeling hearing aid use as a dynamic system can predict outcomes and quantify the relationship between hearing aid intervention and changes in patient behavior, indicating a promising approach for assessing treatment efficacy in challenging populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of counted behaviors in a single-subject design: modeling of hearing-aid intervention in hearing-impaired patients with Alzheimer's disease. Durrant, JD., Palmer, CV., Lunner, T.[2019]

Elderly individuals experience greater difficulties in understanding speech compared to younger individuals with similar hearing loss, often due to age-related changes in the central auditory nervous system.

Improving the signal-to-noise ratio can effectively help mitigate the challenges posed by auditory processing disorders in older adults, leading to better outcomes with hearing aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Special hearing aid considerations in elderly patients with auditory processing disorders. Stach, BA., Loiselle, LH., Jerger, JF.[2019]

In a study involving 31 older hearing aid users and 6 young normal-hearing listeners, those with mild hearing deficits performed better in speech recognition tasks compared to those with more severe deficits, highlighting the variability in outcomes based on hearing loss severity.

The effectiveness of hearing aids in improving speech-in-noise outcomes was found to be significantly influenced by the degree of hearing loss and the specific gain settings of the devices, suggesting that current fitting strategies may not adequately address the needs of users with pronounced hearing deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Three Auditory Profiles on Aided Speech Perception in Different Noise Scenarios. Wu, M., Cañete, OM., Schmidt, JH., et al.[2021]

A meta-analysis of six studies involving 171 Alzheimer's Disease (AD) patients and 222 age-matched controls found that individuals with AD have significantly poorer hearing, with an average increase of 2.3 dB HL at lower frequencies (0.5-2 kHz) and 4.5 dB HL at higher frequencies (0.5-4 kHz).

This study highlights the importance of quantifying hearing loss in AD patients, suggesting that hearing impairment may serve as a potential biomarker for earlier diagnosis and treatment strategies for Alzheimer's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pure Tone Audiometry and Hearing Loss in Alzheimer's Disease: A Meta-Analysis. Kwok, SS., Nguyen, XT., Wu, DD., et al.[2023]

In a study of 114,862 adults aged 66 and older with hearing loss, the use of hearing aids was associated with a reduced risk of being diagnosed with Alzheimer's disease or dementia (hazard ratio of 0.82), anxiety or depression (0.89), and injurious falls (0.87) within three years of hearing loss diagnosis.

The study highlighted significant disparities in hearing aid usage among different sexes and racial/ethnic groups, with men and white individuals using hearing aids more frequently than women and minority groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Hearing Aids Delay Time to Diagnosis of Dementia, Depression, or Falls in Older Adults? Mahmoudi, E., Basu, T., Langa, K., et al.[2020]

Sensorineural hearing loss affects 30 to 50% of older adults, significantly impacting their ability to understand speech and enjoy daily activities, but it is not an unavoidable part of aging.

Advancements in hearing aid technology have made them more accessible and effective for elderly individuals, emphasizing the importance of early identification and routine screening for better management of hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric hearing loss: myths, realities, resources for physicians. Weinstein, BE.[2005]

The prototype digital hearing aid significantly improved speech recognition in patients with sensorineural hearing loss, achieving maximum intelligibility levels of 90-100% in 6 out of 10 patients tested.

In addition to benefiting those with sensorineural hearing loss, the device also provided improvements in speech recognition for patients using conventional hearing aids, demonstrating its potential effectiveness across different types of hearing impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical design and evaluation of the prototype of a new digital audioprosthesis for profound hearing loss: speech recognition aspects. Urquiza, R., Ruiz-Rico, R., Tejero, C., et al.[2017]

Out of 312 patients fitted with hearing aids over 16 months, only 35.5% were optimally supplied, indicating a significant need for better fitting processes and follow-up assessments.

A substantial 71.8% of fitting reports were inadequately completed, which likely contributed to the need for complete refitting in 33% of patients, highlighting the importance of thorough documentation in hearing aid fittings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The importance of hearing-aid testing by the otorhinolaryngologist]. Schorn, K.[2006]

In a study involving 10 patients with mixed hearing loss, both the National Acoustic Laboratories (NAL) and Desired Sensation Level (DSL) fitting algorithms for bone-anchored hearing aids produced similar audiological outcomes over an average of 7 months.

Patients with poorer hearing thresholds showed a preference for the DSL program, which provided better word recognition in quiet environments, suggesting that the DSL may be more beneficial for those with greater hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone-Anchored Hearing Aids Fitted According to NAL and DSL Procedures in Adults with Mixed Hearing Loss. Bruschini, L., Canelli, R., Guida, M., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of Hearing Aids on the Cognitive Status of Patients with Alzheimer's Disease and Hearing Loss: A Multicenter Controlled Randomized Trial. [2018]

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

Reduction in caregiver-identified problem behaviors in patients with Alzheimer disease post-hearing-aid fitting. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Experiences of hearing aid use among patients with mild cognitive impairment and Alzheimer's disease dementia: A qualitative study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Analysis of counted behaviors in a single-subject design: modeling of hearing-aid intervention in hearing-impaired patients with Alzheimer's disease. [2019]

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

Special hearing aid considerations in elderly patients with auditory processing disorders. [2019]

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

Influence of Three Auditory Profiles on Aided Speech Perception in Different Noise Scenarios. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Pure Tone Audiometry and Hearing Loss in Alzheimer's Disease: A Meta-Analysis. [2023]

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

Can Hearing Aids Delay Time to Diagnosis of Dementia, Depression, or Falls in Older Adults? [2020]

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

Geriatric hearing loss: myths, realities, resources for physicians. [2005]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical design and evaluation of the prototype of a new digital audioprosthesis for profound hearing loss: speech recognition aspects. [2017]

11. Germany pubmed.ncbi.nlm.nih.gov

[The importance of hearing-aid testing by the otorhinolaryngologist]. [2006]

12. Turkey pubmed.ncbi.nlm.nih.gov

Bone-Anchored Hearing Aids Fitted According to NAL and DSL Procedures in Adults with Mixed Hearing Loss. [2022]