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Cochlear Implants in Young Children With SSD

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05775367
Collaborator
Med-El Corporation (Industry)
60
Enrollment
1
Location
3
Arms
84
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cochlear Implant
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Other
Official Title:
Cochlear Implantation in Infants and Toddlers With Single-Sided Deafness
Anticipated Study Start Date :
May 30, 2023
Anticipated Primary Completion Date :
May 30, 2030
Anticipated Study Completion Date :
May 30, 2030

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Group

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

Device: Cochlear Implant
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.
Other Names:
  • MED-EL SYNCHRONY 2 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.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Secondary Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Months to 71 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    To be eligible to participate in this trial as a study subject, an individual must meet all of the following criteria:

    1. Provision of signed and dated parental permission form

    2. Unilateral severe-to-profound sensorineural hearing loss, congenital or acquired prior to the age of 2 years, defined as:

    3. 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

    4. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).

    1. 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.

    1. Insufficient functional access to sound with appropriately fit amplification and aural habilitation (based on best practices and standard of care) defined as:

    2. PEACH + parent questionnaire scores below the expected value for children who lack the requisite language to complete open-set word recognition testing or

    3. 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.

    4. Between 7 months and 2 years, 11 months of age at implantation

    5. 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.

    6. No malformation of the cochlea more severe than incomplete partition 2

    7. No evidence of progressive hearing loss of the contralateral ear

    8. 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.

    9. 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

    10. Willing to obtain recommended meningitis vaccinations per Centers for Disease Control (CDC) recommendations

    11. Development and cognition within the normal range as measured by the Developmental Assessment of Young Children (DAYC-2).

    12. 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:

    1. Provision of signed and dated parental permission form

    2. Unilateral severe-to-profound hearing loss - congenital or acquired prior to 2 years of age.

    3. Unaided residual hearing thresholds that yield a 3 frequency PTA (500, 1000, and 2000 Hz) of ≥70 dB HL in the affected ear.

    4. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz)

    5. Unable to use or benefit from traditional amplification

    6. Five years of age at the time of testing

    7. 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:

    1. Provision of signed and dated parental permission form

    2. Bilateral hearing thresholds that yield a PTA of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).

    3. Five years of age at the time of testing

    4. 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:

    1. English is not primary language of the home

    2. Speech perception materials are presented in English

    3. Parental questionnaires are administered in English

    4. Conductive hearing loss in either ear

    5. Cochlear nerve deficiency

    6. Ossification/Fibrosis of the cochlea precluding implantation

    7. Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)

    8. 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:

    1. English is not primary language of the home

    2. Speech perception materials are presented in English

    3. Parental questionnaires are administered in English

    4. Inability to participate in testing (i.e., unwillingness)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Children's Cochlear Implant Center at UNC Durham North Carolina United States 27713

    Sponsors and Collaborators

    • University of North Carolina, Chapel Hill
    • Med-El Corporation

    Investigators

    • Principal Investigator: Lisa Park, AuD, University of North Carolina, Chapel Hill

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT05775367
    Other Study ID Numbers:
    • 22-0862
    First Posted:
    Mar 20, 2023
    Last Update Posted:
    Mar 21, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by University of North Carolina, Chapel Hill
    cochlear implant
    uhl
    ssd
    children
    hearing loss
    deafness
    Additional relevant MeSH terms:
    Hearing Loss
    Deafness
    Hearing Loss, Unilateral

    Study Results

    No Results Posted as of Mar 21, 2023