NCT04240561 · RECRUITING
Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia
This trial is testing two different hearing aid signal processing approaches in older adults who have Alzheimer's dementia or amnestic mild cognitive impairment and also have hearing loss. One approach heavily modifies the sound signal; the other keeps it simpler and more natural. Researchers want to know which works better for people with reduced cognitive capacity. This is a Phase NA study, meaning it is a practical comparison rather than a drug efficacy trial.
You may qualify if
- 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.
You're excluded if
- 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)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-04-30