Over-the-counter Hearing Aids and Mild Cognitive Impairment

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this study is to better understand if, in patients with mild to moderate hearing loss who are also experiencing mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD), Over-the-Counter (OTC) hearing aids: 1. improve communication 2. Whether the magnitude of benefit depends on the patient's level of cognitive disability, 3. Whether alternative remediation (such as targeted communication strategies) offer similar benefits. Participants and a communication partner will be randomized into an OTC first or Communication Strategies first arm, where participants will receive communication strategy information customized for those with cognitive impairment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 90
Healthy Volunteers: f
View:

• Over 60 years of age

• Mild dementia or mild cognitive impairment. Diagnosis will be made at participating memory evaluation centers (see recruitment).

• Mild to moderate bilateral hearing loss and no current hearing aid use.

• A communication partner who is able and willing to participate in the study.

• No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration)

• Able to provide own consent as evaluated by the Consent Assessment

Locations
United States
Illinois
Northwestern University HA Lab
RECRUITING
Evanston
Wisconsin
La Crosse Mayo Clinic
ENROLLING_BY_INVITATION
La Crosse
UW Madison
RECRUITING
Madison
Contact Information
Primary
Kendra Marks
kendra.marks@northwestern.edu
8474670897
Time Frame
Start Date: 2024-07-23
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 50
Treatments
Other: OTC Hearing Aid First
Participants will be provided a pair of OTC hearing aids (experimental) with typical directions and use for 4 weeks before outcome measures will be assessed. After which, participants will then receive the communication strategies information/counseling (control) and have outcome measures assessed after 4 weeks.
Other: Communication Strategies First
Participants will receive the communication strategies information/counseling intervention (control) first. Outcome measures will be assessed at 4 weeks. After which, participants will then be given a pair of OTC hearing aids (experimental) with typical directions and use for four weeks before having outcome measures assessed.
Sponsors
Leads: Northwestern University

This content was sourced from clinicaltrials.gov