Effect of Donepezil on Speech Recognition in Cochlear Implant Users

StatusCompleted
PhaseEarly Phase 1
Started

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Record History

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  1. Minor Trial completed
    • Primary completion date changed from estimate of Sep 1, 2026 to Oct 1, 2026
    • Eligibility criteria expanded, about 20 words
  2. Notable Primary and study completion dates: Sep 1, 2025 to Sep 1, 2026v9
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  4. Minor Eligibility criteria shortened, about 12 wordsv7
  5. Minor Eligibility criteria expanded, about 111 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description shortened, about 9 words
    v6
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  1. Minor Start date changed from estimate of Jan 2023 to Mar 10, 2023
    • Eligibility criteria shortened, about 5 words
    v5
  2. Notable Start date: Oct 2022 to Jan 2023
    • Study description shortened, about 148 words
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 1, 2022 to Oct 2022
    • Study sites: 0 to 1
    v3
  4. Minor Study description expanded, about 215 wordsv2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05438264
Lead Sponsor Vanderbilt University Medical Center
Conditions
(from sponsor)
Bilateral Sensorineural Hearing Loss
Related terms Hearing Loss, Sensorineural
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov