CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 17 enrolled
Drug / intervention
Audiologist-based fitting +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04049643
NCT04049643N/ACompleted

Impact of Hearing Aid Intervention on Individuals With Cognitive Disorders

Yu-Hsiang Wu·interventional·Posted Aug 8, 2019·Updated Apr 17, 2025

In Brief

A clinical study evaluating Audiologist-based fitting, Service-only Fitting, and 1 other intervention for Presbycusis, Bilateral and 2 related conditions. Completed, enrolled 17 participants across 2 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 8, 2019
Enrollment StartDec 1, 2019
Primary CompletionNov 7, 2024
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 6.9 years ago

Interventions

Audiologist-based fittingdevice

Hearing aids will be fitted by audiologists using established procedures.

Service-only Fittingdevice

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-only fittingdevice

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.