Effect of Donepezil on Speech Recognition in Cochlear Implant Users

NCT05438264 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 220844
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Bilateral Sensorineural Hearing Loss

Keywords

cochlear implant; sensorineural hearing loss; donepezil

Outcome Measures

Primary Outcomes (1)

• Postoperative monosyllabic word recognition

  Monosyllabic word recognition using consonant-nucleus-consonant (CNC) word lists

  3 months

Secondary Outcomes (1)

• Cognitive outcome

  3 months

Study Arms (2)

Experimental

EXPERIMENTAL

Donepezil 5 mg, daily

Drug: Donepezil

Control

PLACEBO COMPARATOR

Placebo, daily

Drug: Placebo

Interventions

Donepezil DRUG

acetylcholinesterase inhibitor

Also known as: Aricept

Experimental

Placebo DRUG

placebo

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 6 months of cochlear implant use
• Age ≥ 18 years
• Post-lingual onset of deafness
• Audiometric thresholds meeting FDA-labeled indications for adult cochlear implantation
• 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
• Female participants must have no child-bearing potential or agree to practice effective contraception during the study (such as established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; condom with spermicidal foam/gel/film/cream/suppository; occlusive cap with spermicidal foam/gel/film/cream/suppository; male partner sterilization; or true abstinence when this is in line with the preferred and usual lifestyle of the subject)
• Female participants of child-bearing potential must have a negative urine pregnancy test at the time of enrollment and before each study visit

You may not qualify if:

• 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)
• Positive urine pregnancy test at any time during the study
• Breastfeeding or nursing at any time during the study
• Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives
• 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
• Severe anatomic abnormalities of the temporal bone
• Major active life-threatening illness

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• René Gifford, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Mark Wallace, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Aaron Moberly, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Otolaryngology

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: March 10, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)