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Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants

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ClinicalTrials.gov Identifier: NCT03156465
Recruitment Status : Recruiting
First Posted : May 17, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Bruce J Gantz, University of Iowa

Brief Summary:
The purpose of this feasibility study is to evaluate whether implantation of one Nucleus L24 electrode array and one FDA approved standard-length device in the contralateral ear can provide useful binaural hearing in pediatric subjects who have bilateral severe to profound hearing loss, meeting the criteria for cochlear implantation. Unlike a conventional cochlear implant, the Nucleus L24 is expected to preserve the regions of the cochlear partition that are apical to the electrode, thus leaving them available for possible future advances in the field of otolaryngology and hearing devices, such as mammalian hair cell regeneration techniques or improved implantable hearing devices. Whether or not this group of children will be able to take advantage of future hair cell regeneration strategies is yet to be determined and will have to wait for future development. At this time there are no accurate imaging strategies available to identify preservation of the scala media. Ultra thin micro CT scanning is in development, however the level of radiation delivery to the subject is too great to be considered for clinical use. When imaging strategies become available to determine cellular structure of the inner ear, they will be applied to this group of subjects. The Nucleus L24 array stimulates the basal turn of the cochlea, in an attempt to preserve the middle and apical regions of the scala media.

Condition or disease Intervention/treatment Phase
Implants, Cochlear Child Hearing Loss, Bilateral Device: Hybrid L24 Not Applicable

Detailed Description:

The purpose of this feasibility study is to evaluate whether a Nucleus L24 and a FDA approved standard-length device in the contralateral ear can provide useful binaural hearing in pediatric subjects who have bilateral profound hearing loss, meeting the criteria for cochlear implantation. Unlike a conventional cochlear implant, the Nucleus L24 is designed to preserve the regions of the cochlear partition that are apical to the electrode, thus leaving them available for possible future advances in the field of otolaryngology and hearing devices, such as mammalian hair cell regeneration techniques or improved implantable hearing devices. The Nucleus L24 (16 mm) array stimulates the basal turn of the cochlea, in an attempt to preserve the middle and apical regions of the scala media.

The study will be conducted as a repeated-measure, single-subject experiment. A single-subject research design (in which each participant serves as his or her own control) is appropriate because it accommodates the heterogeneity that characterizes hearing-impaired populations. Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.

Preoperatively, candidates will be assessed with their current amplification to evaluate their appropriateness for entrance into the study. The candidates' audiometric configuration must meet the above inclusion criteria. That is, the candidate must have a profound sensorineural hearing loss from 250 to 8000 Hz. Prior to testing, the appropriateness of the hearing aid fitting will be assessed and adjustments made if necessary. In cases where amplification has not been used for more than one year, new hearing aids will be fit, worn for a minimum three-month trial and the participants re-evaluated to confirm continuance with the study.

Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears. The investigator will alternate every other subject between the right and left ears as to which ear gets the Nucleus L24. Postoperatively, the right ear only, left ear only, and the bilateral listening modes will be compared with repeated testing through five years of age of the child. These comparisons will help to evaluate the effects of bilateral stimulation using a shorter electrode cochlear implant to possibly preserve the scala media, organ of Corti, and supporting cells for future medical interventions and a standard length implant on the contralateral ear. In addition, the investigator will attempt to compare speech perception and speech/language measure results with age-matched children implanted with standard-length bilateral devices.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: repeated-measure, single-subject experiment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants
Actual Study Start Date : September 15, 2011
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hybrid L24 and Standard CI
Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears.
Device: Hybrid L24
Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears.




Primary Outcome Measures :
  1. The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) [ Time Frame: PreOperative ]
    Parent questionnaire that consists of ten questions regarding a young infant or toddler's auditory behavior, e.g. "Does the child spontaneously respond to his/her name in quiet with auditory cues?" Each question is scored on a five point scale: 0=never, 1=rarely, 2=occasionally, 3=frequently, and 4=always. The aim of this tool is to assess the benefit of the child's personal amplification device(s). This questionnaire is generally used during the cochlear implant work-up to assess hearing aid benefit. It is also used post-cochlear implantation to chart the progress the child is making with his/her cochlear implant when other formalized speech perception tests are not appropriate.

  2. The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) [ Time Frame: Post-operative through 2 years ]
    Parent questionnaire that consists of ten questions regarding a young infant or toddler's auditory behavior, e.g. "Does the child spontaneously respond to his/her name in quiet with auditory cues?" Each question is scored on a five point scale: 0=never, 1=rarely, 2=occasionally, 3=frequently, and 4=always. The aim of this tool is to assess the benefit of the child's personal amplification device(s). This questionnaire is generally used during the cochlear implant work-up to assess hearing aid benefit. It is also used post-cochlear implantation to chart the progress the child is making with his/her cochlear implant when other formalized speech perception tests are not appropriate.

  3. The Glendonald Auditory Screening Procedure Word Test (GASP) [ Time Frame: Post-operatively through study completion (child is 5 years of age) or until the child scores 90% or better in all test conditions ]
    Speech perception test that contains 12 single-syllable and multisyllable words. The child will be tested in the bilateral listening condition. This test is always administered in a live-voice mode. The child is asked to repeat the word presented by the clinician. The child is encouraged to use sign if his or her verbal approximations are not clear to the clinician. This test is the easiest open-set measure in this battery because it includes common vocabulary and the speaker is familiar. It can be administered to children as young as two years of age.

  4. The Early Speech Perception Four Choice Spondee and Monosyllable [ Time Frame: Post-operatively through study completion (child is 5 years of age) or until the child scores 90% or better in all test conditions ]
    Speech perception tests that requires the identification of a spondee or monosyllable from a set of four spondees (i.e., French fry, airplane, hotdog, popcorn) or monosyllables (i.e., ball, book, bird, boat), respectively presented in quiet. The CID test will be scored as total number of words correct. It will be administered in both the unilateral and bilateral listening conditions at 70 dB C.

  5. The Multisyllabic Lexical Neighborhood Test [ Time Frame: Post-operatively through study completion at which time the child is 5 years of age. ]
    Open-set word recognition tests. The experimenter gives a list of 24 words and the participants are expected to repeat the word after each presentation. The MLNT consists of two parallel lists. The LNT and MLNT are based on the lexical characteristics of word frequency and neighborhood density, and include words found in the vocabularies of children age three to five. The child will be tested in the bilateral listening condition at 70 dB C.

  6. Phonetically Balanced-Kindergarten [ Time Frame: Post-operatively through study completion at which time the child is 5 years of age. ]
    The PB-K test has multiple 50 word lists. The test will be scored as total number of words correct as well as phonemically. It will be administered in both the unilateral and bilateral listening conditions at 70 dB C


Secondary Outcome Measures :
  1. The Preschool Language Scale-3 (PLS-3) [ Time Frame: Pre-Operative ]
    A standardized language test that is used to measure the language development of children with normal hearing aged 0 months to 83 months. The test evaluates "Expressive Communication" and "Auditory Comprehension" and is designed to evaluate skills in a variety of areas: vocal development, social communication, attention, semantics (content), structure (form), and integrative thinking skills.

  2. The Preschool Language Scale-3 (PLS-3) [ Time Frame: Post-operatively through study completion at which time the child is 5 years of age. ]
    A standardized language test that is used to measure the language development of children with normal hearing aged 0 months to 83 months. The test evaluates "Expressive Communication" and "Auditory Comprehension" and is designed to evaluate skills in a variety of areas: vocal development, social communication, attention, semantics (content), structure (form), and integrative thinking skills.

  3. Peabody Picture Vocabulary Development Scale (PPVT). [ Time Frame: Post-operatively through study completion at which time the child is 5 years of age. ]
    The PPVT (Dunn & Dunn, 1997) is a standardized, norm-referenced measure of receptive vocabulary skills. The test is a multiple-choice measure consisting of sets of four black and white line drawings. The examiner names one of the pictures and the test recipient is expected to indicate which picture has been labeled, either verbally or through pointing.

  4. Goldman-Fristoe Test of Articulation-2 [ Time Frame: Post-operatively through study completion at which time the child is 5 years of age. ]
    The GFTA-2 is a standardized, norm-based articulation measure that samples spontaneous sound production. Children are asked to respond to picture plates and verbal cues from the examiner with single words that test consonant accuracy in initial, medial, and final positions. This measure has norms based on the performance of normal-hearing children from age 2 years to 21 years.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Twelve to twenty-four months of age at the time of implantation.
  2. Audiometric thresholds for frequencies 250 to 8000 Hz in the profound hearing range bilaterally. The type of hearing loss must be categorized as sensorineural in nature.
  3. English spoken as a primary language (mono-lingual English speaking family, where English is the primary language).
  4. Willingness to comply with all study requirements.
  5. Minimum of three-month hearing aid trial with appropriately fit hearing aids.
  6. Patent cochlea and normal cochlear anatomy as shown by a CT scan. It is standard clinical practice to perform a CT scan on any patient pursuing cochlear implantation.

Exclusion Criteria:

  1. Medical or psychological conditions that contraindicate undergoing surgery.
  2. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
  3. Developmental disabilities or other conditions that would prevent or restrict participation in the audiological evaluations and clinical trial.
  4. Hearing loss of neural or central origin.
  5. Unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
  6. Unwillingness or inability of the candidate to comply with all investigational requirements.
  7. Active middle ear infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156465


Contacts
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Contact: Camille C Dunn, PhD 319-353-8776 camille-dunn@uiowa.edu
Contact: Diane Burke, RN 319-356-1765 diane-burke@uiowa.edu

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52241
Contact: Camille C Dunn, Phd    319-353-8776    camille-dunn@uiowa.edu   
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Bruce J Gantz, MD         
Sponsors and Collaborators
Bruce J Gantz
Investigators
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Principal Investigator: Bruce J Gantz, MD University of Iowa

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Responsible Party: Bruce J Gantz, Department Head -- Department of Otolaryngology, University of Iowa
ClinicalTrials.gov Identifier: NCT03156465     History of Changes
Other Study ID Numbers: 201109746
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Bilateral
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms