What is the mechanism of action of this treatment?

Sensorineural hearing loss (SNHL) treatments often focus on enhancing neural plasticity and improving auditory processing. Donepezil, an acetylcholinesterase inhibitor, works by increasing cholinergic activity, which can facilitate cortical reorganization and improve speech recognition and cognitive function in cochlear implant users. This is crucial for SNHL patients as it helps the brain adapt to new auditory inputs, potentially leading to better hearing outcomes and improved quality of life. Other treatments, such as neurotropic therapy, aim to support neural health and recovery, further aiding in the adaptation and processing of auditory information.

What side effects are associated with this type of intervention?

Common treatments for sensorineural hearing loss, such as Donepezil, which is an acetylcholinesterase inhibitor, aim to enhance cholinergic activity to facilitate cortical reorganization. Known side effects of Donepezil include gastrointestinal issues (nausea, diarrhea, vomiting), muscle cramps, fatigue, insomnia, and potential bradycardia. These side effects are important to consider when evaluating the suitability of Donepezil for improving speech recognition and cognitive outcomes in cochlear implant users.

What prior FDA approvals exist?

Currently, there are no FDA-approved medications specifically for the treatment of sensorineural hearing loss (SNHL). Treatments like cochlear implants are commonly used to restore hearing in individuals with moderate to profound SNHL. Research is ongoing to explore the potential benefits of drugs like Donepezil, an acetylcholinesterase inhibitor, which may enhance cholinergic activity and facilitate cortical reorganization, potentially improving outcomes for cochlear implant users. However, these approaches are still under investigation and not yet approved for clinical use in SNHL.

What other types of research exist?

Promising novel alternatives to Donepezil for sensorineural hearing loss patients include cochlear implants combined with increased daily processor use, which has shown potential in improving speech recognition and cognitive outcomes. Additionally, research into molecularly targeted therapies, such as those affecting the sonic hedgehog pathway or other neuroplasticity-related mechanisms, may offer new avenues for treatment.

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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

Must not have

Current or prior use of cholinesterase inhibitors

Major active life-threatening illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial tests whether donepezil can help adult cochlear implant users improve their hearing and cognitive functions. Donepezil boosts brain chemicals important for memory and learning, which may help the brain better process sounds from the implant. The study aims to see if this leads to better speech recognition and cognitive outcomes.

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.

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.

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have used or am using medication to improve memory.

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I do not have a severe illness that threatens my life.

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I have severe structural issues with my ear bone.

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I am currently taking medication known to have anticholinergic effects.

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I have a diagnosed neurological or sensory disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postoperative monosyllabic word recognition

Secondary study objectives

Cognitive outcome

Side effects data

From 2009 Phase 4 trial • 220 Patients • NCT00177671

Suicide Attempt

Myocardial infarcation with congestive heart failure

stroke

100%

80%

60%

40%

20%

Study treatment Arm

Donepezil

Placebo

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment1 Intervention

Donepezil 5 mg, daily

Group II: ControlPlacebo Group1 Intervention

Placebo, daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Donepezil

FDA approved

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Sensorineural hearing loss (SNHL) treatments often focus on enhancing neural plasticity and improving auditory processing. Donepezil, an acetylcholinesterase inhibitor, works by increasing cholinergic activity, which can facilitate cortical reorganization and improve speech recognition and cognitive function in cochlear implant users. This is crucial for SNHL patients as it helps the brain adapt to new auditory inputs, potentially leading to better hearing outcomes and improved quality of life. Other treatments, such as neurotropic therapy, aim to support neural health and recovery, further aiding in the adaptation and processing of auditory information.

Cochlear injury and adaptive plasticity of the auditory cortex.[The role of neurotropic therapy in the treatment of acute sensorineural impairment of hearing following a viral infection].Glial cell line-derived neurotrophic factor and chronic electrical stimulation prevent VIII cranial nerve degeneration following denervation.