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ACTIVE NOT RECRUITING
NCT05438264
EARLY_PHASE1

Effect of Donepezil on Speech Recognition in Cochlear Implant Users

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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. The investigators predict that cholinergic enhancement with donepezil (an acetylcholinesterase inhibitor) may facilitate cortical reorganization in cochlear implant users, leading to functional improvements in speech recognition and cognition. In addition to taking donepezil, study participants will be asked to increase their daily processor use. Studies suggest that increasing daily device use can improve speech recognition, and this study will explore whether this effect can be augmented further with donepezil. In this randomized, double-blind controlled trial, the investigators 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. Participants will be followed longitudinally at 1 month and 3 months after starting the study. 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.

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-03-10

Completion Date

2026-09-01

Last Updated

2025-10-02

Healthy Volunteers

No

Interventions

DRUG

Donepezil

acetylcholinesterase inhibitor

DRUG

Placebo

placebo

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States