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Acetylcholinesterase Inhibitor

Donepezil for Hearing Loss

Phase < 1
Led By René Gifford, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trialaims to see if donepezil can improve hearing & cognition for those with sensorineural hearing loss, who may use cochlear implants for restoration.

Who is the study for?
Adults over 18 with post-lingual deafness, using a cochlear implant for at least 6 months but less than 11 hours per day. Must be in good health, not pregnant or nursing, non-smokers for the last month, and without major neurological disorders or severe ear abnormalities. Women must use effective contraception and have a negative pregnancy test.Check my eligibility
What is being tested?
The trial is testing if Donepezil improves speech recognition and cognitive function in cochlear implant users compared to a placebo. Participants will increase daily device use alongside taking either Donepezil or a placebo pill to see if it enhances hearing outcomes.See study design
What are the potential side effects?
Donepezil may cause side effects like nausea, diarrhea, insomnia, muscle cramps, fatigue and loss of appetite. It can also lead to more serious heart-related issues such as slow heartbeat in some individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am 18 years old or older.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative monosyllabic word recognition
Secondary outcome measures
Cognitive outcome

Side effects data

From 2009 Phase 4 trial • 220 Patients • NCT00177671
Suicide Attempt
Myocardial infarcation with congestive heart failure
Study treatment Arm

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
Donepezil 5 mg, QD
Group II: ControlPlacebo Group1 Intervention
Placebo, QD
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,107 Total Patients Enrolled
René Gifford, PhDPrincipal InvestigatorVanderbilt University Medical Center
Mark Wallace, PhDPrincipal InvestigatorVanderbilt University

Media Library

Donepezil (Acetylcholinesterase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05438264 — Phase < 1
Sensorineural Hearing Loss Research Study Groups: Experimental, Control
Sensorineural Hearing Loss Clinical Trial 2023: Donepezil Highlights & Side Effects. Trial Name: NCT05438264 — Phase < 1
Donepezil (Acetylcholinesterase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05438264 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants will join this experiment?

"Affirmative. According to information found on clinicaltrials.gov, this investigation is presently recruiting participants. This trial was first shared online on October 1st 2022 and the details were last altered two weeks later, on October 18th 2022. The research team requires 50 patients from a single medical facility."

Answered by AI

Is this study enrolling participants aged 20 years or older?

"This research endeavour is open to applicants aged 18 and younger than a century."

Answered by AI

To what demographic is enrollment in this experiment accessible?

"To qualify for inclusion in this trial, applicants should have complete sensorineural hearing loss and be aged between 18 to 100. This study is set to accept a total of 50 participants."

Answered by AI

Are there any unfilled vacancies in this trial that are available to participants?

"Per the details listed on clinicaltrials.gov, this medical study is still recruiting participants as of October 18th 2022 - just over two weeks after its initial posting date of October 1st 2022."

Answered by AI
~28 spots leftby Sep 2025