Bilateral Sensorineural Hearing LossEarly Phase 1NCT05438264
Effect of Donepezil on Speech Recognition in Cochlear Implant Users
A Early Phase 1 study testing Donepezil in people with Bilateral Sensorineural Hearing Loss, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bilateral Sensorineural Hearing Loss
- What is being tested?
- Donepezil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2023to 1 Oct 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
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.
Read the 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 donepezil treatment improves speech recognition in cochlear implant users.
Aim 2: Evaluate if donepezil treatment increases intramodal auditory cortex activity in cochlear implant users.
Aim 3: Evaluate if donepezil treatment improves cognition in cochlear implant users.
- Conditions
- Bilateral Sensorineural Hearing Loss
- Being tested
- Donepezil, Placebo
- Keywords
- cochlear implant, sensorineural hearing loss, donepezil
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Also called Aricept
acetylcholinesterase inhibitor
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Donepezil 5 mg, daily Receives: Drug: Donepezil |
| Control | Placebo comparator | Placebo, daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative monosyllabic word recognition
Monosyllabic word recognition using consonant-nucleus-consonant (CNC) word lists
Measured: 3 months
Secondary outcomes (1)
Cognitive outcome
NIH Cognitive Toolbox and Repeatable Battery for the Assessment of Neuropsychological Status for Hearing Impaired Individuals
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start10 Mar 2023
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Sensorineural Hearing LossStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Moberly, Vanderbilt University Medical Center
- Investigators
- René Gifford, PhD, Principal investigator, Vanderbilt University Medical CenterMark Wallace, PhD, Principal investigator, Vanderbilt UniversityAaron Moberly, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438264
- Sponsor's protocol ID
- 220844
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2022
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will share raw de-identified summary data upon request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Donepezil on Speech Recognition in Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT05438264
- Acronym / sponsor ID
- 220844
- Conditions
- Bilateral Sensorineural Hearing Loss
- Keywords
- cochlear implant, sensorineural hearing loss, donepezil
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 donepezil treatment improves speech recognition in cochlear implant users.
Aim 2: Evaluate if donepezil treatment increases intramodal auditory cortex activity in cochlear implant users.
Aim 3: Evaluate if donepezil treatment improves cognition in cochlear implant users.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: DonepezilDonepezil 5 mg, daily |
| Control | Placebo comparator | Drug: PlaceboPlacebo, daily |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DonepezilAlso: Ariceptacetylcholinesterase inhibitor | Drug | Experimental |
| Placeboplacebo | Drug | Control |
Primary outcome
Postoperative monosyllabic word recognition
Time frame: 3 months
Monosyllabic word recognition using consonant-nucleus-consonant (CNC) word lists
1 secondary outcome
Cognitive outcome
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. The investigators will share raw de-identified summary data upon request.
Related trials for Bilateral Sensorineural Hearing Loss
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
Otoferlin Gene-mediated Hearing Loss
Active, not recruiting
Performance of a Remote Microphone Compared to Hearing Aids Alone
Hearing Loss, Bilateral Sensorineural
Active, not recruiting
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Hearing Loss, Sensorineural, Hearing Loss
Active, not recruiting
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
Hearing Loss, Bilateral Sensorineural
RecruitingPhase 3
Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss
Sensorineural Hearing Loss, Bilateral
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René Gifford, PhD principal investigator
Vanderbilt University Medical Center
Mark Wallace, PhD principal investigator
Vanderbilt University
Aaron Moberly, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Donepezil in people with Bilateral Sensorineural Hearing Loss, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative monosyllabic word recognition (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.