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Prosthesis
Cochlear Implant for Single-Sided Deafness
N/A
Recruiting
Led By Lisa Park, AuD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between 7 months and 2 years, 11 months of age at implantation
No evidence of progressive hearing loss of the contralateral ear
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years of age
Awards & highlights
Study Summary
This trial will explore if cochlear implants are a safe and effective treatment for single-sided deafness in infants and toddlers.
Who is the study for?
This trial is for infants and toddlers aged 7 months to under 3 years with severe-to-profound hearing loss in one ear, which isn't getting better with hearing aids. They should be generally healthy, have normal development and cognition, and their families must speak English at home. Kids can't join if they have certain inner ear abnormalities, lack of cochlear nerve, or conditions that make surgery risky.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of cochlear implants in young children with single-sided deafness. It involves implanting a device into the child's ear and monitoring their hearing abilities up until age five compared to kids without implants or those with normal hearing.See study design
What are the potential side effects?
Cochlear implants may cause side effects like discomfort at the implant site, risk of infection, possible impact on residual natural hearing ability, ringing in the ears (tinnitus), dizziness or balance issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 7 months and 2 years, 11 months old.
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My hearing in the opposite ear is stable.
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My inner ear structure is mostly normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years of age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years of age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Difference in Localization Error Between the Study Group and the SSD Control group Measured at 5 Years of Age
Mean Difference in the Signal-to-Noise Ratio 50 (SNR-50) between the Study Group and SSD Control Group as Measured with the BKB-SIN at 5 Years of Age
Secondary outcome measures
Proportion of Device-Related Adverse Events 6 Months after Surgery
Proportion of Procedural Related Adverse Events 6 months after Surgery
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Study GroupExperimental Treatment1 Intervention
This group of children with single-sided deafness will receive a cochlear implant.
Group II: Typical Hearing Control Group (THCG)Active Control1 Intervention
This group of five-year-old children will have typical hearing in both ears.
Group III: Single-Sided Deafness Control Group (SSDCG)Active Control1 Intervention
This group of five-year-old children will have single-sided deafness and no cochlear implant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cochlear Implant
2019
N/A
~310
Find a Location
Who is running the clinical trial?
Med-El CorporationIndustry Sponsor
23 Previous Clinical Trials
953 Total Patients Enrolled
1 Trials studying Single-Sided Deafness
10 Patients Enrolled for Single-Sided Deafness
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,982 Total Patients Enrolled
Lisa Park, AuDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your cochlear nerve looks normal in the images taken by the doctor.You have severe hearing loss in one ear that started before you turned 2 years old.Parents have practical expectations.My child is between 7 months and 2 years, 11 months old.My mental and learning abilities are considered normal.I am willing to get meningitis vaccinations.I have a problem with the nerve that connects my ear to my brain.I have a history of severe ear infections or a condition that makes anesthesia risky.My inner ear has hardening that prevents implant surgery.My hearing in the opposite ear is stable.English is not the main language spoken in my home.You have trouble hearing even with a hearing aid.I am willing to try or have tried a hearing aid.My inner ear structure is mostly normal.I have hearing loss due to problems in my ear canal or middle ear.
Research Study Groups:
This trial has the following groups:- Group 1: Study Group
- Group 2: Typical Hearing Control Group (THCG)
- Group 3: Single-Sided Deafness Control Group (SSDCG)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is this clinical trial open to applicants who are octogenarians?
"This clinical trial has been designed for participants aged between 7 months to 71 months old. Furthermore, there are 53 and 138 trials respectively tailored towards minors and seniors."
Answered by AI
Is there an opportunity for me to partake in this experiment?
"This clinical trial is recruiting 60 participants aged between 7 and 71 months to test the efficacy of a potential remedy for single-sided deafness."
Answered by AI
Is enrollment open for this investigation at the present time?
"Unfortunately, this trial is no longer actively enrolling patients. First posted on May 30th 2023 and last updated two months ago, the 173 other trials listed are currently seeking volunteers."
Answered by AI
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