Effect of Donepezil on Speech Recognition in Cochlear Implant Users

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Brief Title

Effect of Donepezil on Speech Recognition in Cochlear Implant Users

Official Title

Effect of Donepezil on Speech Recognition in Cochlear Implant Users

Brief 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, the
      investigators 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, 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 at the time of cochlear implant activation. Participants
      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.
    

Detailed Description

      The proposed study is a double-blind, randomized controlled trial comparing donepezil with
      placebo in adult cochlear implant users.

      Aim 1: Evaluate if six months of donepezil treatment improves speech recognition in cochlear
      implant users.

      Aim 2: Evaluate if six months of donepezil treatment increases intramodal auditory cortex
      activity in cochlear implant users.

      Aim 3: Evaluate if six months of donepezil treatment improves cognition in cochlear implant
      users.

      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
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Postoperative monosyllabic word recognition

Secondary Outcome

 Cognitive outcome

Condition

Bilateral Sensorineural Hearing Loss

Intervention

Donepezil

Study Arms / Comparison Groups

 Experimental
Description:  Donepezil 5 mg, QD

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

September 1, 2022

Completion Date

September 1, 2025

Primary Completion Date

September 1, 2025

Eligibility 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
      

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

René Gifford, PhD, 9083873074, [email protected]



Administrative Informations


NCT ID

NCT05438264

Organization ID

220844


Responsible Party

Principal Investigator

Study Sponsor

Vanderbilt University Medical Center


Study Sponsor

René Gifford, PhD, Principal Investigator, Vanderbilt University Medical Center


Verification Date

July 2022