N/A
N=17
Hearing Aid and Individuals With Cognitive Disorders
Presbycusis, Bilateral · Alzheimer Disease 2 Due to Apoe4 Isoform · Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT04049643 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Hearing Aid Benefit as Measured by the International Outcomes Inventory for Hearing Aids (IOI-HA) — 3.9; 3.4; 3.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Audiologist-based fitting (Device); Service-only Fitting (Device); Device-only fitting (Device)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Yu-Hsiang Wu
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hearing Aid Benefit as Measured by the International Outcomes Inventory for Hearing Aids (IOI-HA) |
3.9; 3.4; 3.7 | — |
| PRIMARY Change of Daily Activity as Measured by the Lawton Instrumental Activities of Daily Living Scale (IADL) |
1; 0; 0 | — |
| PRIMARY Change of Caregiver Burden as Measured by the "Zarit Burden Interview" (ZBI) |
-2.6; -7; -1 | — |
| SECONDARY Change of Hearing Handicap Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA) |
-36; -14; -17.5 | — |
| SECONDARY Change of Quality of Life as Measured by the Alzheimer's Disease-Related Quality of Life (ADRQL) |
5.0; 13.8; 1.25 | — |
| SECONDARY Change of Depression as Measured Using the Geriatric Depression Scale (GDS) |
-0.85; 0.5; -0.33 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04049643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.