Understanding Hearing Aid Outcomes in Older Adults with Alzheimer's Dementia
Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia
This study is testing how different hearing aid settings can help older adults with Alzheimer's dementia and memory issues understand speech better and have more successful conversations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT04240561 on ClinicalTrials.gov |
What this trial studies
This project aims to explore how different hearing aid signal processing strategies affect older adults with Alzheimer's dementia and amnestic mild cognitive impairment. The researchers hypothesize that individuals with lower cognitive abilities will benefit more from simpler hearing aid settings that preserve the original sound. By comparing two common signal processing approaches, the study seeks to identify which method yields better speech intelligibility and conversation outcomes for these patients. The ultimate goal is to tailor hearing aid technology to individual auditory and cognitive profiles to enhance patient satisfaction and effectiveness.
Who should consider this trial
Good fit: Ideal candidates are English-speaking older adults diagnosed with Alzheimer's dementia or amnestic mild cognitive impairment who have specific levels of sensorineural hearing loss.
Not a fit: Patients with clinically significant unstable or progressive medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved hearing aid outcomes for older adults with cognitive impairments, enhancing their communication abilities and quality of life.
How similar studies have performed: While there have been studies on hearing aid effectiveness, this specific approach focusing on cognitive ability and signal processing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Speak English as their primary language 2. Normal or corrected to normal vision (20/40 binocular vision or unaided using a Snellen chart) 3. Sensorineural hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 500 and 3000 Hz and a 4 frequency (.5, 1, 2, 3 kHz) pure-tone average of greater than or equal to 30 dB in each ear 4. Clinical Dementia Rating (CDR) of 0.5 or 1 (indicating slight or mild cognitive impairment in the areas of memory, orientation, judgment/problem solving, community affairs, behavior at home/hobbies, and personal care) 5. Diagnosis of dementia Alzheimer's type or amnestic mild cognitive impairment (minimum MoCA score of 18). 6. Living at home 7. Minimum Grade 10 education 8. 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 (e.g. stroke or brain tumor), neurodevelopmental disorder (e.g. Down's syndrome), or head/neck cancer 3. Positive history of major psychiatric disorder (e.g. schizophrenia, significant untreated depression) 4. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies 5. Conductive hearing loss pathology, congenital hearing loss, or fluctuating hearing loss 6. Current active hearing aid wearer (defined as wearing hearing aid(s) at least 4 hours a day for most days within the past year)
Where this trial is running
Chicago, Illinois and 1 other locations
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Northwestern University — Evanston, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Pam Souza, PhD — Northwestern University
- Study coordinator: Kendra Marks, Au.D.
- Email: kendra.marks@northwestern.edu
- Phone: 847-467-0897
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.