RECRUITING

Cochlear Implants in Young Children With SSD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Cochlear Implantation in Infants and Toddlers With Single-Sided Deafness

Quick Facts

Study Start:2023-07-07
Study Completion:2030-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05775367

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Months to 71 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Lisa Park, AuD
CONTACT
9842152871
lisa_park@med.unc.edu
Study Coordinator
CONTACT
919-966-5251
CIResearch@unc.edu

Principal Investigator

Lisa Park, AuD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

The Children's Cochlear Implant Center at UNC
Durham, North Carolina, 27713
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Lisa Park, AuD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-07
Study Completion Date2030-05-30

Study Record Updates

Study Start Date2023-07-07
Study Completion Date2030-05-30

Terms related to this study

Keywords Provided by Researchers

  • cochlear implant
  • uhl
  • ssd
  • children
  • hearing loss
  • deafness

Additional Relevant MeSH Terms

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