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Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial

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ClinicalTrials.gov Identifier: NCT04793412
Recruitment Status : Not yet recruiting
First Posted : March 11, 2021
Last Update Posted : May 20, 2021
Sponsor:
Collaborators:
St. Louis Children's Hospital
University of Southern California
Children's Hospital of Philadelphia
Hearts for Hearing
University of Minnesota
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
This is a two-phase study that compares performance growth pre-implant with current hearing aid (HA) technology versus post-implant with a cochlear implant (CI) in children with either asymmetric hearing loss (AHL) or single-sided deafness (SSD). Post-implant performance with a CI alone is expected to outperform pre-implant performance with a HA. The study also evaluates the effectiveness of bimodal hearing defined as a CI in the poor ear and a HA in the better ear for AHL or a CI in the poor ear and normal hearing in the better ear for SSD compared to pre-implant performance. The study examines factors contributing to CI outcomes.

Condition or disease Intervention/treatment Phase
Asymmetric Hearing Loss Single-sided Deafness Unilateral Deafness Device: Cochlear Implant Not Applicable

Detailed Description:
The study is conducted as a multicenter, prospective, two-phase clinical trial, evaluating the efficacy and safety of cochlear implantation in children with asymmetric hearing loss (AHL) or single-sided deafness (SSD). A hearing aid (HA) phase occurs over a minimum of 4 mos prior to obtaining a cochlear implant (CI). A CI phase occurs over the 15-month period after initial activation of the CI. The AHL/SSD groups are tested for change in performance pre- to post-implant. Investigators also collect longitudinal data over 12 months (matching the 3 to 15 month post-implant timeframe) from normal hearing (NH) participants to provide additional information about outcome trajectory due to development alone. The NH participants are matched to AHL/SSD participants on age, gender and parent education. Post-implant performance with a CI alone is expected to outperform pre-implant performance with a HA. The study evaluates the effectiveness of bimodal hearing defined as a CI in the poor ear and a HA in the better ear for AHL or a CI in the poor ear and normal hearing in the better ear for SSD compared to pre-implant performance. The study examines factors contributing to CI outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The study is conducted as a multicenter, prospective, two-phase clinical trial, evaluating the efficacy and safety of cochlear implantation in children with asymmetric hearing loss (AHL) or single-sided deafness (SSD). A hearing aid (HA) phase occurs over a minimum of 4 mos prior to obtaining a cochlear implant (CI). A CI phase occurs over the 15-month period after initial activation of the CI.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AHL/SSD
Children with asymmetric hearing loss or single-sided deafness
Device: Cochlear Implant
Cochlear implantation of a device from one of the three manufacturers available in the US.




Primary Outcome Measures :
  1. Change in Poor ear alone word recognition in quiet from Pre-Implant to 12 months post-implant [ Time Frame: Pre-Implant and 12 months post-implant ]
    Poor ear alone CNC monosyllabic word recognition in quiet with the CI alone compared to pre-implant with a HA.

  2. Change in Bimodal speech understanding in noise from Pre-Implant to 15 months post-implant [ Time Frame: Pre-implant and 15 months post-implant ]
    Speech reception thresholds (SRTs) for understanding words in noise in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) post-implant compared to the pre-implant best aided condition.

  3. Post-implant bimodal vs better ear alone speech understanding in noise [ Time Frame: 15 months post-implant ]
    Post-implant speech reception thresholds (SRTs) for understanding words in noise in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) compared to the better ear alone condition.

  4. Change in pre-implant trajectory of Bimodal speech understanding in noise over time to post-implant trajectory over time [ Time Frame: 5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits ]
    The trajectory of speech reception thresholds (SRT) for understanding noise throughout the CI Phase (5 visits post-implant) in the bimodal condition is compared to the trajectory throughout the HA Phase (5 visits pre-implant) in the best aided condition.


Secondary Outcome Measures :
  1. Change in Poor ear alone audibility from Pre-Implant to 12 months post-implant [ Time Frame: Pre-implant and 12 months post-implant ]
    FM tone sound field threshold levels in the poor ear alone with a CI compared to pre-implant threshold levels with a HA

  2. Change in Bimodal sound localization from Pre-Implant to 15 months post-implant [ Time Frame: Pre-implant and 15 months post-implant ]
    RMS error scores for a sound localization task in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) post-implant compared to the pre-implant best aided condition.

  3. Change in Bimodal soft speech understanding from Pre-Implant to 12 months post-implant [ Time Frame: Pre-implant and 12 months post-implant ]
    CNC monosyllabic word recognition at a soft level in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) post-implant compared to the pre-implant best aided condition.

  4. Change in PedsQL-MFS ratings from Pre-Implant to 15 months post-implant [ Time Frame: Pre-implant and 15 months post-implant ]
    Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings.

  5. Change in SSQ ratings from Pre-Implant to 15 months post-implant [ Time Frame: Pre-implant and 15 months post-implant ]
    Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings.

  6. Change in HEAR-QL ratings from Pre-Implant to 15 months post-implant [ Time Frame: Pre-implant and 15 months post-implant ]
    Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings.

  7. Post-implant bimodal vs better ear alone sound localization [ Time Frame: 15 months post-implant ]
    Post-implant RMS error scores for the sound localization task are compared in the bimodal condition to the better ear alone condition.

  8. Post-implant bimodal vs better ear alone soft speech understanding [ Time Frame: 12 months post-implant ]
    Post-implant word recognition scores at soft levels are compared in the bimodal condition to the better ear alone condition.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 4 ys of age and up to 14 yrs, 11 mos of age and able to complete all investigational procedures.
  • Parents and child fluent in English. Parents desire bilateral hearing for their child, are willing to comply with study requirements, including the pre-implant HA phase, and are able to provide informed consent.
  • Poor ear (AHL/SSD): PTA at .5, 1, 2 kHz > 70 dB HL; Aided CNC word recognition score at 60 dB SPL < 40%; SPHL duration ≥ 6 mos and ≤ 10 yrs at time of CI surgery; If > 5 yrs of age, evidence of non-congenital SPHL onset (e.g., passed newborn hearing screening); If ≤ 5 yrs of age, no restrictions on SPHL onset.
  • Better ear
  • AHL: PTA at .5, 1, 2, 4 kHz > 25 and ≤ 60 dB HL; Aided CNC word score at 60 dB SPL ≥ 55%; Currently using a HA; Stable hearing for the past 6-mo period. "Stable" is defined as thresholds that have not declined by more than 20 dB at three or more octave-interval audiometric frequencies.
  • SSD: PTA at .5, 1, 2, 4 kHz ≤ 25 dB HL; CNC word score at 60 dB SPL ≥ 70%; Stable hearing for the past 6-mo period.
  • Both ears of NH participants: PTA at .5, 1, 2, 4 kHz ≤ 25 dB HL.
  • To continue with cochlear implantation and into the CI phase of the study: Indication, via imaging, of a normal cochlear nerve and of cochlear anatomy in the ear to be implanted that allows full insertion of the electrode array. Imaging modality is at the discretion of the surgeon. In addition, better ear hearing must be stable throughout the HA phase.

Exclusion Criteria for AHL/SSD Participants:

  • Medical condition that contraindicates surgery; Actively using an implantable device in the ear to be implanted; Inability to complete study procedures; Unrealistic expectations related to the benefits and limitations of implantation; Unwillingness or inability to comply with all investigational requirements.
  • Exclusions for cochlear implantation and the CI phase of the study: Cochlear malformation or obstruction that would preclude full insertion of the electrode array in the ear to be implanted; Abnormal cochlear nerve in the ear to be implanted; Hearing loss of neural or central origin.

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): NCT04793412


Contacts
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Contact: Noel Dwyer, AuD 314-362-7245 NDwyer@wustl.edu
Contact: Laura Holden, AuD 314-362-7245 laurakholden@wustl.edu

Locations
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United States, California
Keck School of Medicine of the University of Southern California
Los Angeles, California, United States, 90033
Contact: Laurie S Eisenberg, PhD    213-764-2826    laurie.eisenberg@med.usc.edu   
Contact: Karen C Johnson, PhD    213-764-2909    karen.johnson@med.usc.edu   
Principal Investigator: Laurie S Eisenberg, PhD         
United States, Minnesota
Fairview Health Services
Minneapolis, Minnesota, United States, 55454
Contact: Kristin Gravel, AuD    612-365-8318    kgravel1@fairview.org   
Contact: Jennifer Ward, AuD    612-365-8311    jward3@fairview.org   
Principal Investigator: Kristin Gravel, AuD         
United States, Missouri
Washington University School of Medicine/St Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
Contact: Jamie Cadieux, AuD    314-454-2201    CadiuxJH@wustl.edu   
Contact: Bernie Rakszawski, AuD    314-454-2201    bernadette.rakszawski@bjc.org   
Principal Investigator: Jill B Firszt, PhD         
United States, Oklahoma
Hearts for Hearing
Oklahoma City, Oklahoma, United States, 73120
Contact: Sara Neumann, AuD    405-548-4300    Sara.Newmann@heartsforhearing.org   
Contact: Stephanie Browning, AuD    405-548-4300    Stephanie.Browning@heartsforhearing.org   
Principal Investigator: Jace Wolf, PhD         
United States, Pennsylvania
Children's Hospital of Philadelphia - Buerger Center
Philadelphia, Pennsylvania, United States, 19104
Contact: Carmen Hayman, AuD    215-590-7461    hayman@email.chop.edu   
Contact: Joy Peterson, AuD    215-590-7620    petersonj@email.chop.edu   
Principal Investigator: John Germiller, MD         
Sponsors and Collaborators
Washington University School of Medicine
St. Louis Children's Hospital
University of Southern California
Children's Hospital of Philadelphia
Hearts for Hearing
University of Minnesota
Investigators
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Principal Investigator: Jill B Firszt, PhD Washington University School of Medicine in St Louis
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04793412    
Other Study ID Numbers: 202007142
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shared through presentations at relevant scientific meetings and through publication(s) in peer-reviewed journals. As required by the NIH Public Access Policy, an electronic version of final manuscripts resulting from this study will be submitted to the NIH National Library of Medicine PubMed Central (PMC) upon acceptance for publication. The few numbers of children at each study site who meet the inclusion criteria and receive a cochlear implant puts participant's privacy at risk if individual data are shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Washington University School of Medicine:
hearing loss
cochlear implant
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Unilateral
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases