Effect of Donepezil on Speech Recognition in Cochlear Implant Users

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Donepezil

Criteria

Inclusion Criteria:

1. Patients who are being evaluated for cochlear implant surgery at VUMC

2. Age ≥ 18 years

3. Post-lingual onset of deafness

4. Audiometric thresholds meeting FDA-labeled indications for adult cochlear implantation: bilateral moderate sloping to profound sensorineural hearing loss (pure tone average ≥ 70 dB HL)

5. Normal or corrected-to-normal vision assessed with a Snellen eye chart

6. English verbal communication

7. No participation in any other clinical trial within the past 3 months

8. Physically healthy

Exclusion Criteria:

1. Evidence of conductive hearing loss

2. Diagnosed neurological or sensory disorder (such as Alzheimer's disease, Parkinson's disease, epilepsy, stroke, autism, schizophrenia, or uncorrected visual impairment)

3. Current use of medications with known anticholinergic effects (such as tricyclic antidepressants, first-generation antihistamines, or bladder antispasmodics)

4. Current or prior use of cholinesterase inhibitors

5. Use of tobacco or nicotine products in the past 1 month

6. Prior cochlear implant surgery

7. Severe anatomic abnormalities of the temporal bone

8. Major active life-threatening illness