Using OTC hearing aids to improve communication in older adults with mild cognitive impairment
Over-the-counter Hearing Aids and Mild Cognitive Impairment
This study is testing if Over-the-Counter hearing aids can help older adults with mild cognitive impairment communicate better compared to just using communication tips.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 60 Years to 90 Years |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 3 sites (Evanston, Illinois and 2 other locations) |
| Trial ID | NCT06112860 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Over-the-Counter (OTC) hearing aids in enhancing communication for individuals over 60 years old who have mild to moderate hearing loss and are experiencing mild cognitive impairment (MCI) or Alzheimer's disease. Participants will be randomized into two groups: one receiving OTC hearing aids and the other receiving communication strategies information. The study will assess whether the benefits of using hearing aids vary based on the level of cognitive impairment and if alternative communication strategies provide similar improvements. The study employs a single-blind cross-over design to ensure objective assessment of outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals over 60 with mild cognitive impairment or mild dementia and mild to moderate bilateral hearing loss who do not currently use hearing aids.
Not a fit: Patients with clinically significant unstable medical conditions or those with unresolved communication difficulties from other neurological issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance communication abilities for older adults with hearing loss and cognitive impairment, improving their quality of life.
How similar studies have performed: Previous studies have shown promising results in improving communication for individuals with hearing loss using various interventions, but this specific approach with OTC hearing aids is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 1. 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. 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 3. Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression) 4. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies. 5. History or current fluctuating hearing loss
Where this trial is running
Evanston, Illinois and 2 other locations
- Northwestern University HA Lab — Evanston, Illinois, United States (Recruiting)
- La Crosse Mayo Clinic — La Crosse, Wisconsin, United States (Enrolling_by_invitation)
- UW Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Pamela Souza, PhD — Northwestern University
- Study coordinator: Kendra Marks
- Email: kendra.marks@northwestern.edu
- Phone: 8474670897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.