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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
Must not have
Cochlear nerve deficiency
History of refractory chronic otitis media or condition that contraindicates anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years of age
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a problem with the nerve that connects my ear to my brain.
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I have a history of severe ear infections or a condition that makes anesthesia risky.
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My inner ear has hardening that prevents implant surgery.
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I have hearing loss due to problems in my ear canal or middle ear.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years of age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Proportion of Device-Related Adverse Events 6 Months after Surgery
Proportion of Procedural Related Adverse Events 6 months after Surgery

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
942 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,555 Previous Clinical Trials
4,298,374 Total Patients Enrolled
Lisa Park, AuDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
28 Total Patients Enrolled

Media Library

Cochlear Implant (Prosthesis) Clinical Trial Eligibility Overview. Trial Name: NCT05775367 — N/A
Neonatal Hearing Loss Research Study Groups: Typical Hearing Control Group (THCG), Study Group, Single-Sided Deafness Control Group (SSDCG)
Neonatal Hearing Loss Clinical Trial 2023: Cochlear Implant Highlights & Side Effects. Trial Name: NCT05775367 — N/A
Cochlear Implant (Prosthesis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05775367 — N/A
~40 spots leftby May 2030
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