Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorNorthwestern University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 (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
Trial design
Design model
Crossover
Treatments tested in this trial
High level of signal manipulation
DeviceHearing aid will be programmed to a high level of signal manipulation.
Low level of signal manipulation
DeviceHearing aid will be programmed to a low level of signal manipulation.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Hearing Aid Fitting Order AExperimental treatment 2 interventions
Group B: Hearing Aid Fitting Order BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change In Speech Intelligibility (%Correct)
Participants will listen to and repeat recorded low-context sentences presented at conversational level at varying levels of background noise. Scoring is determined by percentage of key words in each sentence a participant is able to hear and correctly repeat back to the tester. Scores may range from 0 to 100% and a higher score indicates better understanding (i.e. a better outcome).
Time frame
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
Data will be extracted from conversation samples recorded between person with cognitive impairment and caregiver participants during a mealtime. Conversations will be audio recorded, transcribed ortho graphically and annotated for conversation breakdowns and repairs using Trouble-Source-Repair conventions grounded in Conversation Analysis approaches. Units of measure are: 1)Proportion of problematic talk 2) Proportion of trouble sources 3) Proportion of unsuccessful repairs and 4)Proportion of complex repairs. Reductions in all 4 reflect a positive change.
Time frame
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).Sponsors and contacts
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Northwestern University
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov