Hearing Rehabilitation for Cognitive Impairment

Overseen By Jami Trumbo, MSPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Hearing aid use, Draining ears, others

Compensation: Varies

Number of Visits: 8

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop and test a hearing rehabilitation program specifically for individuals with cognitive impairment, such as Alzheimer's, using a new device and program called HEARS-SLP. The study will evaluate the effectiveness of this treatment when delivered by a speech-language pathologist. Participants will either begin the treatment immediately or after a one-month delay for comparison. Ideal participants are English-speaking individuals who live at home, have been diagnosed with Alzheimer's or related dementia, experience hearing loss, and have a caregiver who assists them regularly. As an unphased trial, this study provides a unique opportunity to contribute to innovative research in hearing rehabilitation for cognitive impairment.

Will I have to stop taking my current medications?

The trial requires that your medication dosage for neuropsychiatric symptoms be stable for at least 2 weeks, so you may not need to stop taking your current medications if they meet this condition.

What prior data suggests that the HEARS-SLP device and program are safe for individuals with cognitive impairment?

Research shows that specific safety information for the HEARS-SLP device or program is not yet available. Detailed studies have not yet determined its safety for individuals. The trial is in an early stage, so researchers are still assessing how participants might respond to the treatment. Early trials typically focus on evaluating a treatment's effectiveness and identifying any side effects. Those concerned about the treatment's safety should consult their doctor before deciding to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HEARS-SLP device and program because they offer a fresh approach to addressing cognitive impairment linked to hearing loss. Unlike traditional hearing aids that simply amplify sound, the HEARS-SLP system combines an innovative device with a specialized program to potentially enhance cognitive functions by improving auditory processing. This dual approach targets not only the hearing issues but also aims to directly boost cognitive health, which could be a game-changer compared to existing treatments that primarily focus on hearing improvement alone.

What evidence suggests that the HEARS-SLP device and program are effective for hearing rehabilitation in individuals with cognitive impairment?

Research shows that the HEARS-SLP treatment, which uses a device and a program, is specifically designed to address hearing and thinking problems. In this trial, participants will join either an immediate treatment arm or a delayed treatment arm. Previous studies on the HEARS model have shown that community-based programs can effectively support hearing health. By involving speech-language pathologists (SLPs) in delivering this treatment, the program aims to make hearing help more accessible and affordable. Early results suggest that using SLPs could enhance the program's effectiveness for individuals with thinking difficulties. This approach is expected to improve communication and overall quality of life for participants. ^{1 2 3 4 5}

Who Is on the Research Team?

Esther Oh, MD, PhD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals aged 60-100 with probable Alzheimer's or related dementia, who live at home and have stable medication dosing. They must have adult-onset hearing loss and a caregiver available to assist with the study.

Inclusion Criteria

You have an average speech frequency pure tone greater than 25 decibels in your better-hearing ear and suffer from adult onset hearing loss.

You have a caregiver/study partner who is available to attend all study-related visits and can provide at least 8 hours of weekly supervision.

I have been diagnosed with Alzheimer's Disease or a similar type of dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Treatment

Participants receive immediate hearing rehabilitative intervention delivered by a speech-language pathologist

1 month

4 visits (in-person)

Delayed Treatment

Participants receive delayed hearing rehabilitative intervention delivered by a speech-language pathologist after a 1-month delay

1 month

4 visits (in-person)

Follow-up

Participants are monitored for changes in neuropsychiatric symptoms and quality of life post-intervention

1 month

What Are the Treatments Tested in This Trial?

Interventions

• HEARS-SLP device
• HEARS-SLP program

Trial Overview The HEARS-SLP program and device are being tested to see if they can help people with cognitive impairment by providing affordable hearing care through speech-language pathologists.

How Is the Trial Designed?

Group I: Immediate treatment Experimental Treatment 2 Interventions

immediate treatment

Group II: Delayed treatment Placebo Group 2 Interventions

1 month delayed treatment

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Despite the potential benefits of auditory training programs for individuals with hearing loss, fewer than 10% of audiologists currently offer these services, which can help reduce the rate of hearing aid returns.

Compliance with home-based auditory training is low, with less than 30% of patients completing the programs, highlighting the need for strategies to improve patient engagement and adherence to therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory training and challenges associated with participation and compliance. Sweetow, RW., Sabes, JH.[2022]

Aging negatively impacts how the brain processes sensory information, particularly in hearing, which can increase the cognitive effort required to understand sounds.

Audiologic rehabilitation techniques, such as hearing aids and listening training, can help reduce the cognitive load needed for effective communication, making it easier for older adults to process auditory signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Listening and Learning: Cognitive Contributions to the Rehabilitation of Older Adults With and Without Audiometrically Defined Hearing Loss. Tremblay, KL., Backer, KC.[2018]

Hearing aids alone do not fully address hearing loss, and many adults still experience low satisfaction and performance, especially in noisy environments, despite advancements in technology.

Auditory training can enhance speech recognition and satisfaction with hearing devices, suggesting that combining technology with training may lead to better outcomes for individuals with hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Options for Auditory Training for Adults with Hearing Loss. Olson, AD.[2022]

Cognitive rehabilitation is a structured intervention that helps individuals recover cognitive skills after a brain injury, using tailored treatment plans based on thorough neuropsychological assessments.

It has been shown to be effective for a range of cognitive impairments, from mild to severe injuries, and can lead to significant improvements in cognitive abilities and overall psychosocial functioning at any time after the injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation following traumatic brain injury: assessment to treatment. Tsaousides, T., Gordon, WA.[2009]

A tablet-based cognitive rehabilitation program called ReMind was evaluated in 62 brain tumor patients, but it did not show significant improvements in cognitive performance or psychological outcomes compared to a control group.

Despite the lack of statistical significance in cognitive outcomes, participants reported high satisfaction with the program, indicating that while the intervention may not have been effective in this study, it could still be beneficial if tailored to better meet patients' needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

eHealth cognitive rehabilitation for brain tumor patients: results of a randomized controlled trial. van der Linden, SD., Rutten, GM., Dirven, L., et al.[2022]

The therapy app developed by Boston University aims to enhance speech, memory, and focus in individuals recovering from traumatic brain injuries or those with conditions like aphasia and dementia.

This app targets essential cognitive and communication skills, potentially providing a valuable tool for rehabilitation in patients with speech-language disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Constant Therapy. [2017]

A study involving 53 older adults with age-related hearing loss showed that a home-based auditory exercises program improved self-assessed hearing abilities, particularly for new hearing aid users after 3 weeks of training.

Results indicated that hearing aid users, including those new to using them, performed better in speech perception tasks compared to non-users, especially in noisy environments, highlighting the benefits of hearing aids in enhancing auditory perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory Perceptual Exercises in Adults Adapting to the Use of Hearing Aids. Karah, H., Karawani, H.[2023]

NeuroPage is a novel device designed to assist with memory and attention dysfunction, functioning more like a prosthetic than a traditional compensatory device, which may enhance its effectiveness in rehabilitation.

The review discusses the clinical implementation of NeuroPage, including necessary training, potential applications, contraindications, and its cost-effectiveness, suggesting it could be a valuable tool in cognitive rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NeuroPage: The Rehabilitation of Memory Dysfunction by Prosthetic Memory and Cueing. Hersh, NA., Treadgold, LG.[2014]

In patients with mild sensorineural hearing loss, passive transcutaneous hearing devices or Bonebridge implants can provide effective audiological outcomes, indicating their suitability for this group.

For patients with combined hearing loss and more significant sensorineural components, Soundbridge or Codacs implants are recommended, with the potential need to evaluate cochlear implants for optimal speech recognition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Device-based treatment of mixed hearing loss: An audiological comparison of current hearing systems]. Rahne, T., Plontke, SK.[2019]

In a study involving 78 elderly adults with hearing impairment, active listening training significantly improved auditory-visual recognition of speech in noisy environments and enhanced psychosocial functioning.

Analytic auditory training did not show effectiveness in improving speech recognition or psychosocial outcomes, suggesting that active listening may be a more beneficial approach for rehabilitation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of audiologic rehabilitation for older adults. Kricos, PB., Holmes, AE.[2020]

In a study involving 85 patients (45 with single-sided deafness and 40 with asymmetric hearing loss), cochlear implants (CIs) demonstrated significant improvements in binaural rehabilitation compared to conventional treatments like (Bi)CROS hearing aids and bone-anchored hearing systems (BAHS).

Patients with long-term acquired deafness (over 10 years) experienced benefits from cochlear implants that were comparable to those with shorter-term deafness, supporting the effectiveness of CIs for a wider range of hearing loss durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cochlear implant treatment of patients with single-sided deafness or asymmetric hearing loss. German version]. Arndt, S., Laszig, R., Aschendorff, A., et al.[2019]

A study involving 15 adult cochlear implant (CI) users showed that a computer-based auditory training program significantly improved their ability to discriminate between phonemes, particularly consonants, over a 3-week period.

The training specifically enhanced discrimination skills for both voiced and unvoiced consonants, indicating that such programs can be effective tools for auditory rehabilitation in CI listeners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Phoneme discrimination training with experienced cochlear implant listeners]. Schumann, A., Liebscher, T., Hoppe, U.[2018]

The review identified only one evidence-based study on computer-based auditory training programs (CBATPs) for children with hearing impairments, highlighting a significant gap in research in this area.

Commercially available CBATPs offer a variety of auditory training activities, but more extensive research is needed to validate their efficacy and establish them as evidence-based practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Based Auditory Training Programs for Children with Hearing Impairment - A Scoping Review. Nanjundaswamy, M., Prabhu, P., Rajanna, RK., et al.[2020]

A survey of 100 speech-language pathologists (SLPs) revealed that while they frequently work with adults who have traumatic brain injury (TBI), many lack confidence and knowledge in this area, indicating a need for improved training.

SLPs reported inconsistent use of evidence-based practices when treating cognitive-communication disorders related to TBI, highlighting the importance of enhancing educational resources and support for these professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge, Confidence, and Practice Patterns of Speech-Language Pathologists Working With Adults With Traumatic Brain Injury. Riedeman, S., Turkstra, L.[2019]

A review of studies on auditory training for older adults with hearing loss since 2013 found that most studies had low to moderate quality, highlighting issues like lack of blinding, control groups, and small sample sizes.

The effectiveness of auditory training remains uncertain, indicating a need for future high-quality randomized controlled trials to better assess long-term outcomes and various measures of effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodological Considerations for Auditory Training Interventions for Adults With Hearing Loss: A Rapid Review. Gaeta, L., Stark, RK., Ofili, E.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06008782?locStr=United+States&country=United+States&aggFilters=status%3A

Providing SLP-Delivered Hearing Health Care to ... Building upon the HEARS audiologist-community health worker (CHW) model, this study intervention will be delivered by a speech-language pathologist (SLP). The ...

2. withpower.com withpower.com/trial/phase-hearing-loss-8-2023-aeeab

Hearing Rehabilitation for Cognitive Impairment The HEARS-SLP treatment is unique because it combines a device and a program specifically designed to address both hearing and cognitive challenges, unlike ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06008782/hears-slp-providing-slp-delivered-hearing-health-care-to-individuals-with-cognitive-impairment

Providing SLP-Delivered Hearing Health Care to ... The primary objective of the study is to develop and test an affordable and accessible hearing rehabilitative intervention that will be delivered by a SLP to ...

4. clinicaltrial.be clinicaltrial.be/en/details/420743?only_active=0&only_eligible=0&only_recruiting=0&per_page=100

Providing SLP-Delivered Hearing Health Care to... The primary objective of the study is to develop and test an affordable and accessible hearing rehabilitative intervention that will be ...

5. clinconnect.io clinconnect.io/trials/NCT02045511

The Baltimore HEARS Pilot Study (NCT02045511) The primary purpose of the study is to develop and test the preliminary efficacy of a first-in-kind community-based intervention to provide affordable, ...