OTC Hearing Aid and MCI

Part of paid clinical trials in Evanston, Illinois.

Sponsor
Northwestern University
Study ID
NCT06112860
Status
Recruiting
Apply to this trial

Conditions

  • Alzheimer Disease and Related Dementias (ADRD)
  • Hearing Loss
  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
60 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Over the counter hearing aid — DEVICE
    An over the counter hearing aid is a device that provides amplification appropriate for individuals with mild to moderate hearing loss. Participants will receive the devices with typical directions and have one scheduled remote visit one week after receiving devices with an audiologist.
  • Communication Strategies Information/Counseling — BEHAVIORAL
    Communication Strategies provide information meant to help an individual compensate for hearing loss. The information provides tips both for the individual with hearing loss and for those communicating. People who choose not to pursue hearing aids will typically be given communication strategies information to help them manage their hearing loss. Participants will receive the counseling information in the mail and then have a 1 week follow-up appointment with an audiologist.

Study Details

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.

Key Dates

Start date
Jul 23, 2024
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT) [ Time Frame: Baseline at enrollment, then after 4 weeks of using each intervention ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Northwestern University HA LabEvanstonIllinois60201
Kendra Marks
[email protected]
La Crosse Mayo ClinicLa CrosseWisconsin54601-
UW MadisonMadisonWisconsin53706
Kendra Marks
[email protected]

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By research site
Northwestern University HA Lab· Evanston, ILLa Crosse Mayo Clinic· La Crosse, WIUW Madison· Madison, WI

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