Trial Summary
What is the purpose of this trial?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 Criteria
This trial is for individuals over 60 with mild dementia or mild cognitive impairment and mild to moderate hearing loss who don't currently use a hearing aid. They must have a partner to communicate with during the study, be able to consent, and not have severe vision impairments.Inclusion Criteria
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
I am over 60 years old.
+3 more
Exclusion Criteria
Co-enrolled in other intervention studies targeting hearing, language, or communication strategies
My hearing loss comes and goes.
Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study
+2 more
Participant Groups
The study aims to see if Over-the-Counter (OTC) hearing aids help improve communication in patients with cognitive challenges and whether targeted communication strategies offer similar benefits. Participants will try either the OTC hearing aid or communication strategies first, then switch.
2Treatment groups
Experimental Treatment
Group I: OTC Hearing Aid FirstExperimental Treatment2 Interventions
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.
Group II: Communication Strategies FirstExperimental Treatment2 Interventions
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern University HA LabEvanston, IL
UW MadisonMadison, WI
La Crosse Mayo ClinicLa Crosse, WI
Loading ...
Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor