Status:
ACTIVE_NOT_RECRUITING
Effect of Donepezil on Speech Recognition in Cochlear Implant Users
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Bilateral Sensorineural Hearing Loss
Eligibility:
All Genders
18-100 years
Phase:
EARLY_PHASE1
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 res...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05438264
Start Date
March 10 2023
End Date
September 1 2026
Last Update
October 2 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203