Effect of Donepezil on Speech Recognition in Cochlear Implant Users

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05438264

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bilateral Sensorineural Hearing Loss	Drug: Donepezil Drug: Placebo	Early Phase 1

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

Patients who are being evaluated for cochlear implant surgery at VUMC
Age ≥ 18 years
Post-lingual onset of deafness
Audiometric thresholds meeting FDA-labeled indications for adult cochlear implantation: bilateral moderate sloping to profound sensorineural hearing loss (pure tone average ≥ 70 dB HL)
Normal or corrected-to-normal vision assessed with a Snellen eye chart
English verbal communication
No participation in any other clinical trial within the past 3 months
Physically healthy

Exclusion Criteria

Evidence of conductive hearing loss
Diagnosed neurological or sensory disorder (such as Alzheimer's disease, Parkinson's disease, epilepsy, stroke, autism, schizophrenia, or uncorrected visual impairment)
Current use of medications with known anticholinergic effects (such as tricyclic antidepressants, first-generation antihistamines, or bladder antispasmodics)
Current or prior use of cholinesterase inhibitors
Use of tobacco or nicotine products in the past 1 month
Prior cochlear implant surgery
Severe anatomic abnormalities of the temporal bone
Major active life-threatening illness

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Donepezil on Speech Recognition in Cochlear Implant Users

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Donepezil 5 mg, QD	Drug: Donepezil acetylcholinesterase inhibitor Other Names: Aricept
Placebo Comparator: Control Placebo, QD	Drug: Placebo placebo

Arm

Intervention/Treatment

Experimental: Experimental

Donepezil 5 mg, QD

Drug: Donepezil

acetylcholinesterase inhibitor

Other Names:

Aricept

Placebo Comparator: Control

Placebo, QD

Drug: Placebo

placebo

Outcome Measures

Primary Outcome Measures

Postoperative monosyllabic word recognition [6 months]
monosyllabic word recognition using consonant nucleus consonant (CNC) word list at 6 months post cochlear implant activation

Secondary Outcome Measures

Cognitive outcome [6 months]
NIH Cognitive Toolbox and Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who are being evaluated for cochlear implant surgery at VUMC
Age ≥ 18 years
Post-lingual onset of deafness
Audiometric thresholds meeting FDA-labeled indications for adult cochlear implantation: bilateral moderate sloping to profound sensorineural hearing loss (pure tone average ≥ 70 dB HL)
Normal or corrected-to-normal vision assessed with a Snellen eye chart
English verbal communication
No participation in any other clinical trial within the past 3 months
Physically healthy

Exclusion Criteria:

Evidence of conductive hearing loss
Diagnosed neurological or sensory disorder (such as Alzheimer's disease, Parkinson's disease, epilepsy, stroke, autism, schizophrenia, or uncorrected visual impairment)
Current use of medications with known anticholinergic effects (such as tricyclic antidepressants, first-generation antihistamines, or bladder antispasmodics)
Current or prior use of cholinesterase inhibitors
Use of tobacco or nicotine products in the past 1 month
Prior cochlear implant surgery
Severe anatomic abnormalities of the temporal bone
Major active life-threatening illness