NCT04240561 Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia
| NCT ID | NCT04240561 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Hearing Loss, Sensorineural |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-07-01 |
| Primary Completion | 2027-08-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This current translational project, funded by NIH, aims to better understand the impact of various signal modification strategies for older adults with Alzheimer's dementia and its potential precursor, known as amnestic mild cognitive impairment. The investigators hypothesize that adults with Alzheimer's dementia represent an extreme case of restricted cognitive ability, such that very low working memory capacity and overall reduced cognitive capacity will limit benefit from advanced signal processing. Thus, the investigators hypothesize that adults with Alzheimer's dementia will receive greater benefit from acoustically simple, high-fidelity hearing aid processing that minimally alters the acoustic signal.
Eligibility 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 un