Hearing Aid and Individuals With Cognitive Disorders

Summary

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.

Conditions

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

Interventions

DEVICE

Audiologist-based fitting

Hearing aids will be fitted by audiologists using established procedures.

DEVICE

Service-only Fitting

This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. In this intervention group, audiological services plus hearing aids that provide minimum amplification will be provided. Specifically, patient participants in this group will receive audiological services (e.g., counselling and education), except that the hearing aids will be set to provide no amplification other than what is needed to overcome any sounds that are dampened by the earpieces.

DEVICE

Device-only fitting

This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. The patient participants in this intervention group will have minimum services regarding the pre-fitting, selection, and orientation of the hearing aids. The participants will have a hearing evaluation, including pure-tone audiometry. The audiologist will select the amplification characteristics and non-custom ear piece based on the audiogram. The audiologist will then briefly orient the participant on how to use the hearing aids and counsel on how to optimize their performance.

Sponsors & Collaborators

• Vanderbilt University Medical Center

  collaborator OTHER

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• Yu-Hsiang Wu

  lead OTHER

Principal Investigators

• Yu-Hsiang Wu, PhD · University of Iowa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-01

Primary Completion

2024-11-07

Completion

2024-11-07

FDA Device

Yes

Countries

• United States

Study Locations