Cochlear Implants in Young Children With SSD

Not Applicable

Recruiting

• Conditions: Hearing Loss, Unilateral; Single Sided Deafness; Deafness One Ear; Unilateral Deafness; Hearing Loss; Congenital Hearing Loss
• Interventions: Device: Cochlear Implant

• Registration Number: NCT05775367
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

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.

Study Timeline

• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-20
• Study Start: 2023-07-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2030-05-30
• Study Completion: 2030-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Cochlear Implant	This group of children with single-sided deafness will receive a cochlear implant.

Primary Outcome Measures

Name	Time	Method
Mean Difference in Localization Error Between the Study Group and the SSD Control group Measured at 5 Years of Age	5 years of age	Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. All participants will be 5 years old at the time of testing. The study group will use their cochlear implant in conjunction with the normal hearing ear. The SSD control group will use their normal hearing ear alone.
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	5 years of age	Two ½ lists of the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) will be presented in a single condition: speech in front and masker directed 90 degrees to the normal ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better. All participants will be 5 years old at the time of testing. The study group will use their cochlear implant in conjunction with the normal hearing ear. The SSD control group will use their normal hearing ear alone.

Secondary Outcome Measures

Name	Time	Method
Proportion of Device-Related Adverse Events 6 Months after Surgery	6 months after surgery	Device related adverse events will be collected and reported as the proportion of subjects experiencing them.
Proportion of Procedural Related Adverse Events 6 months after Surgery	6 months after surgery	Procedural adverse events will be collected and reported as the proportion of subjects experiencing them.

Trial Locations

Locations (1)

The Children's Cochlear Implant Center at UNC; 🇺🇸 Durham, North Carolina, United States