Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia (NCT04240561) | Clinical Trial Compass
RecruitingNot Applicable
Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia
United States20 participantsStarted 2021-07-01
Plain-language 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.
Who can participate
Age range50 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Speak English as their primary language
✓. Normal or corrected to normal vision (20/40 binocular vision or unaided using a Snellen chart)
✓. 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
✓. 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)
✓. Diagnosis of dementia Alzheimer's type or amnestic mild cognitive impairment (minimum MoCA score of 18).
✓. Living at home
✓. Minimum Grade 10 education
✓. 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
What they're measuring
1
Change In Speech Intelligibility (%Correct)
Timeframe: Change from Baseline to final appointment ineach hearing aid condition will be assessed. Participants will take an unaided baseline at the start of the trial. Measure will be repeated at the end of each intervention (3-5 weeks after each fitting).
2
Change in Conversation Analysis of Communication Breakdown
Timeframe: Change from Baseline to final appointment in each hearing aid condition will be assessed. Participants will take an unaided baseline at the start of the trial. Measure will be repeated at the end of each intervention (3-5 weeks after each fitting).
✕. 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
✕. Positive history of major psychiatric disorder (e.g. schizophrenia, significant untreated depression)
✕. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies
✕. Conductive hearing loss pathology, congenital hearing loss, or fluctuating hearing loss
✕. Current active hearing aid wearer (defined as wearing hearing aid(s) at least 4 hours a day for most days within the past year)