Effect of Donepezil on Speech Recognition in Cochlear Implant Users
Status:
Not yet recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
Hearing loss is a major cause of disability that affects over 48 million Americans. There are
currently no medications used to treat sensorineural hearing loss. Cochlear implants can
significantly restore hearing in adults with moderate to profound sensorineural hearing loss,
but their utility is limited by the wide variability in hearing outcomes. Differences in
cochlear implant outcomes may be explained by neuroplasticity, as neural networks must
reorganize to process the new auditory information provided by the implant. Therefore, we
predict that cholinergic enhancement with donepezil (an acetylcholinesterase inhibitor) may
facilitate cortical reorganization after cochlear implantation, leading to functional
improvements in speech recognition and cognition. In this randomized, double-blind controlled
trial, we aim to assess the effects of donepezil on speech recognition, cortical plasticity,
and cognition. Participants will start daily treatment with either donepezil 5 mg or placebo
at the time of cochlear implant activation, and they will be followed longitudinally at 1
month, 3 months, and 6 months post-implantation. The findings from this study will provide
important insight into the mechanisms of hearing restoration and could potentially improve
hearing and cognitive outcomes for future cochlear implant users.