20 Participants Needed

Hearing Rehabilitation for Cognitive Impairment

CL
RC
JT
Overseen ByJami Trumbo, MSPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University

Trial Summary

What is the purpose of this trial?

Building upon the HEARS audiologist-community health worker (CHW) model, this study intervention will be delivered by a speech-language pathologist (SLP). 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 individuals with 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 data supports the effectiveness of the HEARS-SLP treatment for cognitive impairment?

Research shows that cognitive rehabilitation, which includes retraining skills and teaching strategies, is effective for improving cognitive functions like memory and attention. This suggests that treatments like HEARS-SLP, which may involve similar rehabilitation techniques, could be beneficial for cognitive impairment.12345

Is the HEARS-SLP device or program safe for humans?

The research articles reviewed do not provide specific safety data for the HEARS-SLP device or program. However, they discuss auditory training programs in general, which are typically considered safe for use in humans, focusing on improving hearing and speech perception.678910

How is the HEARS-SLP treatment different from other treatments for cognitive impairment related to hearing loss?

The HEARS-SLP treatment is unique because it combines a device and a program specifically designed to address both hearing and cognitive challenges, unlike traditional hearing aids that mainly focus on sound amplification. This approach aims to improve listening strategies and cognitive skills, which are often not addressed by standard hearing aids.1112131415

Research Team

EO

Esther Oh, MD, PhD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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.
See 4 more

Timeline

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

Treatment Details

Interventions

  • HEARS-SLP device
  • HEARS-SLP program
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Immediate treatmentExperimental Treatment2 Interventions
immediate treatment
Group II: Delayed treatmentPlacebo Group2 Interventions
1 month delayed treatment

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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+

Findings from Research

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.
NeuroPage: The Rehabilitation of Memory Dysfunction by Prosthetic Memory and Cueing.Hersh, NA., Treadgold, LG.[2014]
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.
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.
eHealth cognitive rehabilitation for brain tumor patients: results of a randomized controlled trial.van der Linden, SD., Rutten, GM., Dirven, L., et al.[2022]

References

NeuroPage: The Rehabilitation of Memory Dysfunction by Prosthetic Memory and Cueing. [2014]
Cognitive rehabilitation following traumatic brain injury: assessment to treatment. [2009]
eHealth cognitive rehabilitation for brain tumor patients: results of a randomized controlled trial. [2022]
Knowledge, Confidence, and Practice Patterns of Speech-Language Pathologists Working With Adults With Traumatic Brain Injury. [2019]
Constant Therapy. [2017]
Auditory Perceptual Exercises in Adults Adapting to the Use of Hearing Aids. [2023]
[Phoneme discrimination training with experienced cochlear implant listeners]. [2018]
Options for Auditory Training for Adults with Hearing Loss. [2022]
Methodological Considerations for Auditory Training Interventions for Adults With Hearing Loss: A Rapid Review. [2021]
Computer-Based Auditory Training Programs for Children with Hearing Impairment - A Scoping Review. [2020]
[Cochlear implant treatment of patients with single-sided deafness or asymmetric hearing loss. German version]. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Auditory training and challenges associated with participation and compliance. [2022]
[Device-based treatment of mixed hearing loss: An audiological comparison of current hearing systems]. [2019]
14.United Statespubmed.ncbi.nlm.nih.gov
Listening and Learning: Cognitive Contributions to the Rehabilitation of Older Adults With and Without Audiometrically Defined Hearing Loss. [2018]
15.United Statespubmed.ncbi.nlm.nih.gov
Efficacy of audiologic rehabilitation for older adults. [2020]