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.
12345Is 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.
678910How 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.
1112131415Eligibility 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.
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Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Immediate treatmentExperimental Treatment2 Interventions
immediate treatment
Group II: Delayed treatmentPlacebo Group2 Interventions
1 month delayed treatment
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins MedicineBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
National Institute on Aging (NIA)Collaborator
References
NeuroPage: The Rehabilitation of Memory Dysfunction by Prosthetic Memory and Cueing. [2014]Various compensatory devices typically employed in the rehabilitation of memory and attention dysfunction are reviewed. The authors then describe and evaluate a novel compensatory device, NeuroPage, which appears to operate as a prosthetic, rather than simply a compensatory device. Clinical implementation in terms of training, applications, contraindications, and cost-effectiveness is discussed.
Cognitive rehabilitation following traumatic brain injury: assessment to treatment. [2009]Cognitive rehabilitation refers to a set of interventions that aim to improve a person's ability to perform cognitive tasks by retraining previously learned skills and teaching compensatory strategies. Cognitive rehabilitation begins with a thorough neuropsychological assessment to identify cognitive strengths and weaknesses and the degree of change in cognitive ability following a brain injury. The conclusions of the assessment are used to formulate appropriate treatment plans. Common interventions for improvements in attention, memory, and executive function, as well as the nature of comprehensive programs, which combine treatment modalities, are reviewed. Cognitive rehabilitation is effective for mild-to-severe injuries and beneficial at any time post-injury. Sufficient evidence exists supporting the efficacy and effectiveness of cognitive rehabilitation, which has become the treatment of choice for cognitive impairments and leads to improvements in cognitive and psychosocial functioning.
eHealth cognitive rehabilitation for brain tumor patients: results of a randomized controlled trial. [2022]Evidence-based cognitive rehabilitation programs for brain tumor patients are not widely available, despite the high need. We aimed to evaluate the effects of a tablet-based cognitive rehabilitation program on cognitive performance, cognitive complaints, fatigue, and psychological distress in primary brain tumor patients following neurosurgery. Also, attrition, adherence and patient satisfaction with the program were evaluated.
Knowledge, Confidence, and Practice Patterns of Speech-Language Pathologists Working With Adults With Traumatic Brain Injury. [2019]Although speech-language pathologists (SLPs) are important members of the health care team serving adults with traumatic brain injury (TBI) with cognitive-communication disorders, little is known about services SLPs deliver and how they rate their own knowledge and skills. The aims of this study were to identify practice patterns, knowledge, and confidence levels of SLPs working with adults with TBI with cognitive-communication disorders.
Constant Therapy. [2017]Designed by scientists at Boston University, the aim of this therapy app is to improve everyday speech, memory and focus skills in people recovering from traumatic brain injury, or who have aphasia, dementia or a speech-language disorder.
Auditory Perceptual Exercises in Adults Adapting to the Use of Hearing Aids. [2023]Older adults with age-related hearing loss often use hearing aids (HAs) to compensate. However, certain challenges in speech perception, especially in noise still exist, despite today's HA technology. The current study presents an evaluation of a home-based auditory exercises program that can be used during the adaptation process for HA use. The home-based program was developed at a time when telemedicine became prominent in part due to the COVID-19 pandemic. The study included 53 older adults with age-related symmetrical sensorineural hearing loss. They were divided into three groups depending on their experience using HAs. Group 1: Experienced users (participants who used bilateral HAs for at least 2 years). Group 2: New users (participants who were fitted with bilateral HAs for the first time). Group 3: Non-users. These three groups underwent auditory exercises for 3 weeks. The auditory tasks included auditory detection, auditory discrimination, and auditory identification, as well as comprehension with basic (syllables) and more complex (sentences) stimuli, presented in quiet and in noisy listening conditions. All participants completed self-assessment questionnaires before and after the auditory exercises program and underwent a cognitive test at the end. Self-assessed improvements in hearing ability were observed across the HA users groups, with significant changes described by new users. Overall, speech perception in noise was poorer than in quiet. Speech perception accuracy was poorer in the non-users group compared to the users in all tasks. In sessions where stimuli were presented in quiet, similar performance was observed among new and experienced uses. New users performed significantly better than non-users in all speech in noise tasks; however, compared to the experienced users, performance differences depended on task difficulty. The findings indicate that HA users, even new users, had better perceptual performance than their peers who did not receive hearing aids.
[Phoneme discrimination training with experienced cochlear implant listeners]. [2018]Computer-based auditory training programmes seem to be a useful tool in the process of auditory rehabilitation after cochlear implantation (CI). Currently, little is known about the learning mechanism and efficiency of such programs. The aim of the study was to evaluate a specific auditory training programme for phoneme discrimination in experienced CI listeners.
Options for Auditory Training for Adults with Hearing Loss. [2022]Hearing aid devices alone do not adequately compensate for sensory losses despite significant technological advances in digital technology. Overall use rates of amplification among adults with hearing loss remain low, and overall satisfaction and performance in noise can be improved. Although improved technology may partially address some listening problems, auditory training may be another alternative to improve speech recognition in noise and satisfaction with devices. The literature underlying auditory plasticity following placement of sensory devices suggests that additional auditory training may be needed for reorganization of the brain to occur. Furthermore, training may be required to acquire optimal performance from devices. Several auditory training programs that are readily accessible for adults with hearing loss, hearing aids, or cochlear implants are described. Programs that can be accessed via Web-based formats and smartphone technology are reviewed. A summary table is provided for easy access to programs with descriptions of features that allow hearing health care providers to assist clients in selecting the most appropriate auditory training program to fit their needs.
Methodological Considerations for Auditory Training Interventions for Adults With Hearing Loss: A Rapid Review. [2021]Purpose The aim of this study was to evaluate literature on auditory training published since 2013. Method A rapid review or a streamlined approach to systematically identify and summarize relevant studies was performed. Selected health sciences databases were searched using a search strategy developed with the PICO (population, intervention, comparison, and outcome) framework. Studies eligible for inclusion had older adult participants with hearing loss and utilized technology-based auditory training in laboratory or home settings. Results The study quality of most studies was found to be low to moderate, with concentrations between low and moderate. Major issues were related to study design and reporting, such as the need for blinding and a control group, larger sample sizes, and a follow-up for long-term outcomes of auditory training interventions. Wide variability in training approaches, participant backgrounds (e.g., audiograms, hearing aid use), and outcome measures are also noted. Conclusions Evidence on the effectiveness of auditory training is mixed. Future research should include high-quality randomized controlled trials with representative populations; follow-up periods to study long-term effects; and exploration of behavioral, electrophysiological, and self-reported outcome measures. Recommendations for study designs and methodologies are also discussed.
Computer-Based Auditory Training Programs for Children with Hearing Impairment - A Scoping Review. [2020]Introduction  Communication breakdown, a consequence of hearing impairment (HI), is being fought by fitting amplification devices and providing auditory training since the inception of audiology. The advances in both audiology and rehabilitation programs have led to the advent of computer-based auditory training programs (CBATPs). Objective  To review the existing literature documenting the evidence-based CBATPs for children with HIs. Since there was only one such article, we also chose to review the commercially available CBATPs for children with HI. The strengths and weaknesses of the existing literature were reviewed in order to improve further researches. Data Synthesis  Google Scholar and PubMed databases were searched using various combinations of keywords. The participant, intervention, control, outcome and study design (PICOS) criteria were used for the inclusion of articles. Out of 124 article abstracts reviewed, 5 studies were shortlisted for detailed reading. One among them satisfied all the criteria, and was taken for review. The commercially available programs were chosen based on an extensive search in Google. The reviewed article was well-structured, with appropriate outcomes. The commercially available programs cover many aspects of the auditory training through a wide range of stimuli and activities. Conclusions  There is a dire need for extensive research to be performed in the field of CBATPs to establish their efficacy, also to establish them as evidence-based practices.
[Cochlear implant treatment of patients with single-sided deafness or asymmetric hearing loss. German version]. [2019]The rehabilitation of patients with single-sided deafness (SSD) or asymmetric hearing loss can be achieved with conventional (bilateral) contralateral routing of signals ((Bi)CROS) hearing aids ((Bi)CROS-HA, (Bi)CROS), bone-anchored hearing systems (BAHS) or cochlear implants (CI). To date, only small case series have been published on treatment outcomes in SSD patients after CI surgery and there are only a few comparative studies evaluating rehabilitation outcomes.
Auditory training and challenges associated with participation and compliance. [2022]When individuals have hearing loss, physiological changes in their brain interact with relearning of sound patterns. Some individuals utilize compensatory strategies that may result in successful hearing aid use. Others, however, are not so fortunate. Modern hearing aids can provide audibility but may not rectify spectral and temporal resolution, susceptibility to noise interference, or degradation of cognitive skills, such as declining auditory memory and slower speed of processing associated with aging. Frequently, these deficits are not identified during a typical "hearing aid evaluation." Aural rehabilitation has long been advocated to enhance communication but has not been considered time or cost-effective. Home-based, interactive adaptive computer therapy programs are available that are designed to engage the adult hearing-impaired listener in the hearing aid fitting process, provide listening strategies, build confidence, and address cognitive changes. Despite the availability of these programs, many patients and professionals are reluctant to engage in and complete therapy.
[Device-based treatment of mixed hearing loss: An audiological comparison of current hearing systems]. [2019]Various different hearing systems are available for device-supported hearing rehabilitation of patients with mixed hearing loss. Using the recently introduced objective comparison criterion "maximum output" (i.e., the maximum output level of a hearing device), the indications for different hearing devices can be compared.
Listening and Learning: Cognitive Contributions to the Rehabilitation of Older Adults With and Without Audiometrically Defined Hearing Loss. [2018]Here, we describe some of the ways in which aging negatively affects the way sensory input is transduced and processed within the aging brain and how cognitive work is involved when listening to a less-than-perfect signal. We also describe how audiologic rehabilitation, including hearing aid amplification and listening training, is used to reduce the amount of cognitive resources required for effective auditory communication and conclude with an example of how listening effort is being studied in research laboratories for the purpose(s) of informing clinical practice.
Efficacy of audiologic rehabilitation for older adults. [2020]Two intervention procedures for the rehabilitation of elderly adults with hearing impairment were evaluated: analytic auditory training and active listening training. Seventy-eight older adults with hearing loss served as subjects. Twenty-six subjects received no training, 26 received analytic training, and 26 received active listening training. The effectiveness of the audiologic rehabilitation programs was determined via measures of speech recognition, hearing handicap perception, and psychosocial function. Active listening was found to be an effective treatment for helping individuals with hearing impairment improve their auditory-visual recognition of speech in noise and improve certain aspects of their psychosocial functioning. Support for analytic speech recognition drills alone was not demonstrated.