NCT04240561 · Northwestern University
Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
High level of signal manipulation
Hearing aid will be programmed to a high level of signal manipulation.
DEVICE
Low level of signal manipulation
Hearing aid will be programmed to a low level of signal manipulation.
Primary outcome measures
Change In Speech Intelligibility (%Correct)
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).
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).
Change in Conversation Analysis of Communication Breakdown
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).
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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)
Where
- Chicago, Illinois
- Evanston, Illinois
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 30, 2026 · Source of record for eligibility and locations