OTC Hearing Aid and MCI
Recruiting · NCT06112860 · Interventional (participants receive a specific treatment) · Lead sponsor: Northwestern University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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.
- History of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down's syndrome), or head/neck cancer
- Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
- Co-enrolled in other intervention studies targeting hearing, language, or communication strategies.
- History or current fluctuating hearing loss
Where it is running
3 locations listed across 2 US states.
- Northwestern University HA Lab - Evanston, Illinois, United States
- La Crosse Mayo Clinic - La Crosse, Wisconsin, United States
- UW Madison - Madison, Wisconsin, United States