Cochlear Implants in Young Children With SSD

Part of paid clinical trials in Durham, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT05775367
Status
Recruiting
Apply to this trial

Conditions

  • Congenital Hearing Loss
  • Deafness One Ear
  • Hearing Loss
  • Hearing Loss, Unilateral
  • Single Sided Deafness
  • Unilateral Deafness

Eligibility Criteria

Sex
ALL
Age
7 Months - 71 Months
Healthy Volunteers
Accepted

Interventions

  • Cochlear Implant — DEVICE
    A cochlear implant is a surgically implanted device that provides access to sound in people cannot get enough access to sound for communication with traditional hearing aids.

Study Details

The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness. The main questions it aims to answer are: * Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers? * Are cochlear implants a safe treatment for single-sided deafness in infants and toddlers? Participants will receive a cochlear implant and be followed until they are five years old. During those five years, the investigators will program the device and monitor auditory development. Children will be asked to: * Undergo cochlear implantation * Wear their cochlear implant processor whenever they are awake. * Participate in traditional hearing tests * Participate in traditional hearing testing * Participate in localization testing * Participate in hearing in noise testing * Participate in word recognition testing * Participate in speech, language, and educational evaluations The researchers will compare results to children with typical hearing in both ears and children with single-sided deafness who have not received an implant to observe any differences between the groups.

Key Dates

Start date
Jul 7, 2023
Status verified
May 2025
Primary completion
May 30, 2030
Completion
May 30, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Study Group
    This group of children with single-sided deafness will receive a cochlear implant.
  • No Intervention: Typical Hearing Control Group (THCG)
    This group of five-year-old children will have typical hearing in both ears.
  • No Intervention: Single-Sided Deafness Control Group (SSDCG)
    This group of five-year-old children will have single-sided deafness and no cochlear implant.

Primary Outcome Measure

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 [ Time Frame: 5 years of age ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Children's Cochlear Implant Center at UNCDurhamNorth Carolina27713
Lisa Park, AuD
[email protected]
984-215-2871
CI Research
[email protected]
Lisa Park, AuD (PRINCIPAL_INVESTIGATOR)
Erika Gagnon, AuD (SUB_INVESTIGATOR)
Jennifer Woodard, AuD (SUB_INVESTIGATOR)
Lillian Henderson, MSP (SUB_INVESTIGATOR)
Sandra Hancock, MS (SUB_INVESTIGATOR)
Meredith Rooth, AuD (SUB_INVESTIGATOR)
Kevin Brown, MD, PhD (PRINCIPAL_INVESTIGATOR)
Carlton Zdanski, MD (SUB_INVESTIGATOR)
Margaret Richter, AuD (SUB_INVESTIGATOR)
Lauren Leeper, MD (SUB_INVESTIGATOR)
Matthew Dedmon, MD, PhD (SUB_INVESTIGATOR)
A. Morgan Selleck, MD (SUB_INVESTIGATOR)
Dakota Sharp, AuD (SUB_INVESTIGATOR)
Melissa Anderson, AuD (SUB_INVESTIGATOR)
Caitlin Sapp, AuD, PhD (SUB_INVESTIGATOR)
Sarah Spencer, MS (SUB_INVESTIGATOR)
Erin Thompson, MS (SUB_INVESTIGATOR)
Samantha Scharf, AuD (SUB_INVESTIGATOR)

Find similar trials in Durham, NC

By research site
The Children's Cochlear Implant Center at UNC· Durham, NC

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