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Cochlear Implants in Young Children With SSD

Primary Purpose

Single Sided Deafness, Unilateral Deafness, Hearing Loss, Unilateral

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cochlear Implant
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Single Sided Deafness focused on measuring cochlear implant, uhl, ssd, children, hearing loss, deafness

Eligibility Criteria

7 Months - 71 Months (Child)All SexesAccepts Healthy Volunteers

To be eligible to participate in this trial as a study subject, an individual must meet all of the following criteria: Provision of signed and dated parental permission form Unilateral severe-to-profound sensorineural hearing loss, congenital or acquired prior to the age of 2 years, defined as: Unaided residual hearing thresholds that yield a 3 frequency pure tone average (PTA; average at 500, 1000, and 2000 Hz) of ≥70 dB hearing loss (HL) in the ear to be implanted Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz). i. Thresholds should be measured using inserts wherever possible, or in the sound field to record the better-hearing ear alone. Required thresholds will include 250, 500, 1000, 2000, and 4000 Hz for air conduction. All other octave frequencies should be attempted. Bone conduction thresholds should be obtained at 500, 1000, 2000, and 4000 Hz. Masking should be attempted where appropriate. As participants are very young and masking is difficult for this population, suspected shadow audiograms will be sufficient if objective testing has confirmed a severe-to-profound unilateral hearing loss. Testing should confirm a severe-to-profound hearing loss, defined as a 3-frequency PTA (500, 1000, and 2000) >70 dB HL in one ear and ≤20 dB HL in the contralateral ear. The Primary Investigator and Lead Diagnostic Audiologist must agree on this diagnosis for enrollment. Insufficient functional access to sound with appropriately fit amplification and aural habilitation (based on best practices and standard of care) defined as: PEACH + parent questionnaire scores below the expected value for children who lack the requisite language to complete open-set word recognition testing or Recorded Multisyllabic Lexical Neighborhood Test (MLNT) scores ≤ 30% in the ear to be implanted for children with the requisite language to complete open-set word recognition testing. Between 7 months and 2 years, 11 months of age at implantation Normal cochlear nerve as evaluated by imaging, required imaging by MRI brain/Internal auditory canal (IAC) without contrast with heavily weighted T2 images. CT optional at the physician's discretion. No malformation of the cochlea more severe than incomplete partition 2 No evidence of progressive hearing loss of the contralateral ear Willing to/has undergone hearing aid trial as warranted based on achieving an aided speech intelligibility index (SII) of > .65 when fitted via Desired Sensation Level (DSL) methods. Realistic parental expectations: a verbal acknowledgment of the potential benefits and risks, and postoperative variation in performance. For instance, cochlear implantation will not restore normal hearing Willing to obtain recommended meningitis vaccinations per Centers for Disease Control (CDC) recommendations Development and cognition within the normal range as measured by the Developmental Assessment of Young Children (DAYC-2). Parental commitment to study parameters including being able and willing to participate in the evaluation schedule, involvement in prescribed therapy, and travel to the investigational site and study-related activities. Parents must be willing to encourage wearing implant during waking hours. To participate as an SSD control subject, an individual must meet all the following criteria: Provision of signed and dated parental permission form Unilateral severe-to-profound hearing loss - congenital or acquired prior to 2 years of age. Unaided residual hearing thresholds that yield a 3 frequency PTA (500, 1000, and 2000 Hz) of ≥70 dB HL in the affected ear. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz) Unable to use or benefit from traditional amplification Five years of age at the time of testing Development and cognition within the normal range as measured by the Early Stanford Binet 2 (SB2). To participate as a TH control subject, an individual must meet all the following criteria: Provision of signed and dated parental permission form Bilateral hearing thresholds that yield a PTA of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz). Five years of age at the time of testing Development and cognition within the normal range as measured by the Early SB2. An individual who meets any of the following criteria will be excluded from participation in this study as a study subject: English is not primary language of the home Speech perception materials are presented in English Parental questionnaires are administered in English Conductive hearing loss in either ear Cochlear nerve deficiency Ossification/Fibrosis of the cochlea precluding implantation Inability to participate in follow-up procedures (i.e., unwillingness, geographic location) History of refractory chronic otitis media or condition that contraindicates anesthesia An individual who meets any of the following criteria will be excluded from participation in this study as a control subject: English is not primary language of the home Speech perception materials are presented in English Parental questionnaires are administered in English Inability to participate in testing (i.e., unwillingness)

Sites / Locations

  • The Children's Cochlear Implant Center at UNCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Study Group

Typical Hearing Control Group (THCG)

Single-Sided Deafness Control Group (SSDCG)

Arm Description

This group of children with single-sided deafness will receive a cochlear implant.

This group of five-year-old children will have typical hearing in both ears.

This group of five-year-old children will have single-sided deafness and no cochlear implant.

Outcomes

Primary Outcome Measures

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
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.
Mean Difference in Localization Error Between the Study Group and the SSD Control group Measured at 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.

Secondary Outcome Measures

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

Full Information

First Posted
March 7, 2023
Last Updated
July 10, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Med-El Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05775367
Brief Title
Cochlear Implants in Young Children With SSD
Official Title
Cochlear Implantation in Infants and Toddlers With Single-Sided Deafness
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2023 (Actual)
Primary Completion Date
May 30, 2030 (Anticipated)
Study Completion Date
May 30, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Med-El Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Single Sided Deafness, Unilateral Deafness, Hearing Loss, Unilateral, Hearing Loss, Congenital Hearing Loss, Deafness One Ear
Keywords
cochlear implant, uhl, ssd, children, hearing loss, deafness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study group will receive a cochlear implant under the age of three and be tested at the age of five. Two control groups, both five years old, will be tested as well. The control groups will consist of children with typical hearing in both ears and children with single-sided deafness who have not received a cochlear implant.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
This group of children with single-sided deafness will receive a cochlear implant.
Arm Title
Typical Hearing Control Group (THCG)
Arm Type
No Intervention
Arm Description
This group of five-year-old children will have typical hearing in both ears.
Arm Title
Single-Sided Deafness Control Group (SSDCG)
Arm Type
No Intervention
Arm Description
This group of five-year-old children will have single-sided deafness and no cochlear implant.
Intervention Type
Device
Intervention Name(s)
Cochlear Implant
Other Intervention Name(s)
MED-EL SYNCHRONY 2 Cochlear Implant
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
5 years of age
Title
Mean Difference in Localization Error Between the Study Group and the SSD Control group Measured at 5 Years of Age
Description
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.
Time Frame
5 years of age
Secondary Outcome Measure Information:
Title
Proportion of Procedural Related Adverse Events 6 months after Surgery
Description
Procedural adverse events will be collected and reported as the proportion of subjects experiencing them.
Time Frame
6 months after surgery
Title
Proportion of Device-Related Adverse Events 6 Months after Surgery
Description
Device related adverse events will be collected and reported as the proportion of subjects experiencing them.
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
To be eligible to participate in this trial as a study subject, an individual must meet all of the following criteria: Provision of signed and dated parental permission form Unilateral severe-to-profound sensorineural hearing loss, congenital or acquired prior to the age of 2 years, defined as: Unaided residual hearing thresholds that yield a 3 frequency pure tone average (PTA; average at 500, 1000, and 2000 Hz) of ≥70 dB hearing loss (HL) in the ear to be implanted Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz). i. Thresholds should be measured using inserts wherever possible, or in the sound field to record the better-hearing ear alone. Required thresholds will include 250, 500, 1000, 2000, and 4000 Hz for air conduction. All other octave frequencies should be attempted. Bone conduction thresholds should be obtained at 500, 1000, 2000, and 4000 Hz. Masking should be attempted where appropriate. As participants are very young and masking is difficult for this population, suspected shadow audiograms will be sufficient if objective testing has confirmed a severe-to-profound unilateral hearing loss. Testing should confirm a severe-to-profound hearing loss, defined as a 3-frequency PTA (500, 1000, and 2000) >70 dB HL in one ear and ≤20 dB HL in the contralateral ear. The Primary Investigator and Lead Diagnostic Audiologist must agree on this diagnosis for enrollment. Insufficient functional access to sound with appropriately fit amplification and aural habilitation (based on best practices and standard of care) defined as: PEACH + parent questionnaire scores below the expected value for children who lack the requisite language to complete open-set word recognition testing or Recorded Multisyllabic Lexical Neighborhood Test (MLNT) scores ≤ 30% in the ear to be implanted for children with the requisite language to complete open-set word recognition testing. Between 7 months and 2 years, 11 months of age at implantation Normal cochlear nerve as evaluated by imaging, required imaging by MRI brain/Internal auditory canal (IAC) without contrast with heavily weighted T2 images. CT optional at the physician's discretion. No malformation of the cochlea more severe than incomplete partition 2 No evidence of progressive hearing loss of the contralateral ear Willing to/has undergone hearing aid trial as warranted based on achieving an aided speech intelligibility index (SII) of > .65 when fitted via Desired Sensation Level (DSL) methods. Realistic parental expectations: a verbal acknowledgment of the potential benefits and risks, and postoperative variation in performance. For instance, cochlear implantation will not restore normal hearing Willing to obtain recommended meningitis vaccinations per Centers for Disease Control (CDC) recommendations Development and cognition within the normal range as measured by the Developmental Assessment of Young Children (DAYC-2). Parental commitment to study parameters including being able and willing to participate in the evaluation schedule, involvement in prescribed therapy, and travel to the investigational site and study-related activities. Parents must be willing to encourage wearing implant during waking hours. To participate as an SSD control subject, an individual must meet all the following criteria: Provision of signed and dated parental permission form Unilateral severe-to-profound hearing loss - congenital or acquired prior to 2 years of age. Unaided residual hearing thresholds that yield a 3 frequency PTA (500, 1000, and 2000 Hz) of ≥70 dB HL in the affected ear. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz) Unable to use or benefit from traditional amplification Five years of age at the time of testing Development and cognition within the normal range as measured by the Early Stanford Binet 2 (SB2). To participate as a TH control subject, an individual must meet all the following criteria: Provision of signed and dated parental permission form Bilateral hearing thresholds that yield a PTA of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz). Five years of age at the time of testing Development and cognition within the normal range as measured by the Early SB2. An individual who meets any of the following criteria will be excluded from participation in this study as a study subject: English is not primary language of the home Speech perception materials are presented in English Parental questionnaires are administered in English Conductive hearing loss in either ear Cochlear nerve deficiency Ossification/Fibrosis of the cochlea precluding implantation Inability to participate in follow-up procedures (i.e., unwillingness, geographic location) History of refractory chronic otitis media or condition that contraindicates anesthesia An individual who meets any of the following criteria will be excluded from participation in this study as a control subject: English is not primary language of the home Speech perception materials are presented in English Parental questionnaires are administered in English Inability to participate in testing (i.e., unwillingness)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Park, AuD
Phone
9842152871
Email
lisa_park@med.unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
919-966-5251
Email
CIResearch@unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Park, AuD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Cochlear Implant Center at UNC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Park, AuD
Phone
984-215-2871
Email
lisa_park@med.unc.edu
First Name & Middle Initial & Last Name & Degree
CI Research
Email
CIResearch@unc.edu
First Name & Middle Initial & Last Name & Degree
Lisa Park, AuD
First Name & Middle Initial & Last Name & Degree
Erika Gagnon, AuD
First Name & Middle Initial & Last Name & Degree
Jennifer Woodard, AuD
First Name & Middle Initial & Last Name & Degree
Lillian Henderson, MSP
First Name & Middle Initial & Last Name & Degree
Sandra Hancock, MS
First Name & Middle Initial & Last Name & Degree
Margaret Dillon, AuD, PhD
First Name & Middle Initial & Last Name & Degree
Meredith Rooth, AuD
First Name & Middle Initial & Last Name & Degree
Kevin Brown, MD, PhD
First Name & Middle Initial & Last Name & Degree
Carlton Zdanski, MD
First Name & Middle Initial & Last Name & Degree
Margaret Richter, AuD
First Name & Middle Initial & Last Name & Degree
Lauren Leeper, MD
First Name & Middle Initial & Last Name & Degree
Matthew Dedmon, MD, PhD
First Name & Middle Initial & Last Name & Degree
A. Morgan Selleck, MD
First Name & Middle Initial & Last Name & Degree
Dakota Sharp, AuD
First Name & Middle Initial & Last Name & Degree
Melissa Anderson, AuD
First Name & Middle Initial & Last Name & Degree
Caitlin Sapp, AuD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-Identified raw data will be archived at Open Science Framework
IPD Sharing Time Frame
At the time of the first publication following study closure
IPD Sharing URL
https://osf.io/
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Citation
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Links:
URL
https://www.cdc.gov/ncbddd/hearingloss/conference.html
Description
National Workshop on Mild and Unilateral Hearing Loss: Workshop Proceedings

Learn more about this trial

Cochlear Implants in Young Children With SSD

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