Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT05775367
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2023-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cochlear Implants in Young Children With SSD
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Cochlear Implantation in Infants and Toddlers With Single-Sided Deafness
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
Cochlear implantation is an FDA-approved option for children with single-sided deafness (SSD) who are over the age of five years. It has been well established that early implantation is advantageous for children with bilateral hearing loss as it takes advantage of the narrow window of neural plasticity. Research has yet to show the ideal age for implantation in children with SSD but considering the known impacts of age at implantation and duration of deafness on cochlear implant (CI) outcomes, five years is likely a late age for implantation in a child with congenital SSD. The purpose of this prospective clinical trial is to evaluate the safety and effectiveness of cochlear implantation in infants and toddlers with SSD.
Twenty (20) infants and Toddlers with SSD who are under the age of three will receive a cochlear implant. They will be followed until they reach the age of five. A group of typically hearing five-year-olds (n=20) and a group of five-year-olds with congenital or early onset SSD who have not received a cochlear implant (n=20) will also be recruited. All three groups of five-year-olds will be tested on measures of hearing in quiet, localizing, and hearing in spatially separated noise for comparison. Scores from the study group and the SSD control group will be compared to evaluate effectiveness.
The study will also explore the potential effects of SSD and early implantation on language, sensory processing, executive function, fatigue, and cognition.
Twenty (20) infants and Toddlers with SSD who are under the age of three will receive a cochlear implant. They will be followed until they reach the age of five. A group of typically hearing five-year-olds (n=20) and a group of five-year-olds with congenital or early onset SSD who have not received a cochlear implant (n=20) will also be recruited. All three groups of five-year-olds will be tested on measures of hearing in quiet, localizing, and hearing in spatially separated noise for comparison. Scores from the study group and the SSD control group will be compared to evaluate effectiveness.
The study will also explore the potential effects of SSD and early implantation on language, sensory processing, executive function, fatigue, and cognition.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: