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Acetylcholinesterase Inhibitor
Donepezil for Hearing Loss
Phase < 1
Recruiting
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
Timeline
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 belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
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 • NCT001776711%
Suicide Attempt
1%
Myocardial infarcation with congestive heart failure
1%
stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donepezil
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
Donepezil 5 mg, QD
Group II: ControlPlacebo Group1 Intervention
Placebo, QD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Donepezil
FDA approved
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
861 Previous Clinical Trials
672,753 Total Patients Enrolled
René Gifford, PhDPrincipal InvestigatorVanderbilt University Medical Center
Mark Wallace, PhDPrincipal InvestigatorVanderbilt University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have used or am using medication to improve memory.Your hearing loss started after you learned to speak.Your hearing loss is severe enough to be eligible for a cochlear implant according to FDA guidelines.You have a positive pregnancy test during the study.You have normal vision or wear glasses or contacts to correct your vision to normal.I do not have a severe illness that threatens my life.I have severe structural issues with my ear bone.I am in good physical health.I've used my cochlear implant for over 6 months but less than 11 hours daily.I am a woman who can have children and have a negative pregnancy test before joining the study.I am either not able to have children or will use effective birth control during the study.I am currently taking medication known to have anticholinergic effects.I have a diagnosed neurological or sensory disorder.I am 18 years old or older.You are allergic to donepezil hydrochloride or piperidine derivatives.You have used tobacco or nicotine products in the last month.You have a type of hearing loss that affects how sound travels through your ear.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
- Group 2: Control
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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