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Hearing Aid and Individuals With Cognitive Disorders

Y

Yu-Hsiang Wu

Status

Completed

Conditions

Mild Cognitive Impairment
Presbycusis, Bilateral
Alzheimer Disease 2 Due to Apoe4 Isoform

Treatments

Device: Device-only fitting
Device: Audiologist-based fitting
Device: Service-only Fitting

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04049643
3R01DC015997-02S1 (U.S. NIH Grant/Contract)
201907763

Details and patient eligibility

About

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.

Full description

A disorder that often affect older adults is age-related hearing loss. It is estimated that about two-thirds of persons aged 70 years or older exhibit hearing problems. Left untreated, age-related hearing loss can affect an individual's ability to communicate and to interact with his/her environment and can contribute to psychological symptoms such depression, anxiety, isolation, paranoia, and possibly dementia.

Because (1) the neuropsychiatric symptoms associated with dementia could be exacerbated by poor communication resulting from hearing loss and (2) it has been widely accepted that hearing aids (HAs) are effective in improving communication function and reducing the psychosocial consequences associated with hearing loss for older adults without dementia, it seems reasonable to use HAs to treat the hearing loss of adults with Alzheimer's Disease and related dementias (ADRD). However, it has been argued that because the pathology of ADRD could involve central auditory pathways and nuclei, HAs-the devices that improve audibility at the peripheral level of the auditory system-may not be an effective management for ADRD. To date there is no high-quality evidence to support or negate the benefit of HA intervention on adults with dementia in reducing communication difficulty, dementia-related symptoms, and caregiver burdens. Therefore, the benefit of HA intervention on adults with ADRD remains unknown. Further, the best service model to provide HAs for older adults with ADRD is unknown. On one hand, it is likely that customized HAs fitted by audiologists using best practices could generate optimal outcomes. However, implementing the best-practice audiology services is challenging in this population. On the other hand, recent literature suggests that audiologists could fit low-cost, pre-programmed, non-customized amplification devices to adults with ADRD to reduce the cost of HA intervention, while yielding reasonable outcomes.To date there is no high-quality research rigorously examining the outcome, value, and candidacy of different HA service-delivery models for older adults with ADRD.

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 ADRD. We expect that at least a total of 30 patients will complete the pilot study. The collected data will provide valuable information for us to formulate or revise the hypotheses, conduct power analysis, and finalize the research protocol for the future clinical trial.

Enrollment

17 patients

Sex

All

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Montreal Cognitive Assessment (MoCA) score lower than 25 points
  • Adult-onset mild-to-moderate sensorineural hearing loss

Exclusion criteria

  • Non-native English speaker
  • Prior hearing aid experience

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

17 participants in 3 patient groups

Audiologist-Based
Active Comparator group
Description:
In this group, the audiologist-based fitting will be used to provide hearing aids.
Treatment:
Device: Audiologist-based fitting
Service-Only
Experimental group
Description:
In this group, hearing aids that have minimum amplification will be fitted by audiologists.
Treatment:
Device: Service-only Fitting
Device-Only
Experimental group
Description:
In this group, hearing aids will be provided with minimum services from audiologists.
Treatment:
Device: Device-only fitting

Trial documents
2

Trial contacts and locations

2

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Central trial contact

Yu-Hsiang Wu, PhD; Elizabeth Stangl, AuD

Data sourced from clinicaltrials.gov

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