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

Primary Purpose

Asymmetric Hearing Loss, Single-sided Deafness, Unilateral Deafness

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cochlear Implant
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asymmetric Hearing Loss focused on measuring hearing loss, cochlear implant

Eligibility Criteria

4 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Keck School of Medicine of the University of Southern CaliforniaRecruiting
  • Fairview Health ServicesRecruiting
  • Washington University School of Medicine/St Louis Children's HospitalRecruiting
  • Hearts for HearingRecruiting
  • Children's Hospital of Philadelphia - Buerger CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AHL/SSD

Arm Description

Children with asymmetric hearing loss or single-sided deafness

Outcomes

Primary Outcome Measures

Change in Poor ear alone word recognition in quiet from Pre-Implant to 12 months post-implant
Poor ear alone CNC monosyllabic word recognition in quiet with the CI alone compared to pre-implant with a HA.
Change in Bimodal speech understanding in noise from Pre-Implant to 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.
Post-implant bimodal vs better ear alone speech understanding in noise
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.
Change in pre-implant trajectory of Bimodal speech understanding in noise over time to post-implant trajectory over time
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

Change in Poor ear alone audibility from Pre-Implant to 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
Change in Bimodal sound localization from Pre-Implant to 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.
Change in Bimodal soft speech understanding from Pre-Implant to 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.
Change in PedsQL-MFS ratings from Pre-Implant to 15 months post-implant
Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings.
Change in SSQ ratings from Pre-Implant to 15 months post-implant
Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings.
Change in HEAR-QL ratings from Pre-Implant to 15 months post-implant
Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings.
Post-implant bimodal vs better ear alone sound localization
Post-implant RMS error scores for the sound localization task are compared in the bimodal condition to the better ear alone condition.
Post-implant bimodal vs better ear alone soft speech understanding
Post-implant word recognition scores at soft levels are compared in the bimodal condition to the better ear alone condition.

Full Information

First Posted
March 4, 2021
Last Updated
May 31, 2022
Sponsor
Washington University School of Medicine
Collaborators
St. Louis Children's Hospital, University of Southern California, Children's Hospital of Philadelphia, Hearts for Hearing, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT04793412
Brief Title
Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial
Official Title
Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
St. Louis Children's Hospital, University of Southern California, Children's Hospital of Philadelphia, Hearts for Hearing, University of Minnesota

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asymmetric Hearing Loss, Single-sided Deafness, Unilateral Deafness
Keywords
hearing loss, cochlear implant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AHL/SSD
Arm Type
Experimental
Arm Description
Children with asymmetric hearing loss or single-sided deafness
Intervention Type
Device
Intervention Name(s)
Cochlear Implant
Intervention Description
Cochlear implantation of a device from one of the three manufacturers available in the US.
Primary Outcome Measure Information:
Title
Change in Poor ear alone word recognition in quiet from Pre-Implant to 12 months post-implant
Description
Poor ear alone CNC monosyllabic word recognition in quiet with the CI alone compared to pre-implant with a HA.
Time Frame
Pre-Implant and 12 months post-implant
Title
Change in Bimodal speech understanding in noise from Pre-Implant to 15 months post-implant
Description
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.
Time Frame
Pre-implant and 15 months post-implant
Title
Post-implant bimodal vs better ear alone speech understanding in noise
Description
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.
Time Frame
15 months post-implant
Title
Change in pre-implant trajectory of Bimodal speech understanding in noise over time to post-implant trajectory over time
Description
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.
Time Frame
5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits
Secondary Outcome Measure Information:
Title
Change in Poor ear alone audibility from Pre-Implant to 12 months post-implant
Description
FM tone sound field threshold levels in the poor ear alone with a CI compared to pre-implant threshold levels with a HA
Time Frame
Pre-implant and 12 months post-implant
Title
Change in Bimodal sound localization from Pre-Implant to 15 months post-implant
Description
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.
Time Frame
Pre-implant and 15 months post-implant
Title
Change in Bimodal soft speech understanding from Pre-Implant to 12 months post-implant
Description
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.
Time Frame
Pre-implant and 12 months post-implant
Title
Change in PedsQL-MFS ratings from Pre-Implant to 15 months post-implant
Description
Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings.
Time Frame
Pre-implant and 15 months post-implant
Title
Change in SSQ ratings from Pre-Implant to 15 months post-implant
Description
Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings.
Time Frame
Pre-implant and 15 months post-implant
Title
Change in HEAR-QL ratings from Pre-Implant to 15 months post-implant
Description
Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings.
Time Frame
Pre-implant and 15 months post-implant
Title
Post-implant bimodal vs better ear alone sound localization
Description
Post-implant RMS error scores for the sound localization task are compared in the bimodal condition to the better ear alone condition.
Time Frame
15 months post-implant
Title
Post-implant bimodal vs better ear alone soft speech understanding
Description
Post-implant word recognition scores at soft levels are compared in the bimodal condition to the better ear alone condition.
Time Frame
12 months post-implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noel Dwyer, AuD
Phone
314-362-7245
Email
NDwyer@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Holden, AuD
Phone
314-362-7245
Email
laurakholden@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill B Firszt, PhD
Organizational Affiliation
Washington University School of Medicine in St Louis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keck School of Medicine of the University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurie S Eisenberg, PhD
Phone
213-764-2826
Email
laurie.eisenberg@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Karen C Johnson, PhD
Phone
213-764-2909
Email
karen.johnson@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Laurie S Eisenberg, PhD
Facility Name
Fairview Health Services
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Koeritzer, AuD
Phone
612-365-8307
Email
Margaret.Koeritzer@fairview.org
First Name & Middle Initial & Last Name & Degree
Jennifer Ward, AuD
Phone
612-365-8311
Email
jward3@fairview.org
First Name & Middle Initial & Last Name & Degree
Margaret Koeritzer, AuD
Facility Name
Washington University School of Medicine/St Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Cadieux, AuD
Phone
314-454-2201
Email
CadiuxJH@wustl.edu
First Name & Middle Initial & Last Name & Degree
Bernie Rakszawski, AuD
Phone
314-454-2201
Email
bernadette.rakszawski@bjc.org
First Name & Middle Initial & Last Name & Degree
Jill B Firszt, PhD
Facility Name
Hearts for Hearing
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Neumann, AuD
Phone
405-548-4300
Email
Sara.Newmann@heartsforhearing.org
First Name & Middle Initial & Last Name & Degree
Stephanie Browning, AuD
Phone
405-548-4300
Email
Stephanie.Browning@heartsforhearing.org
First Name & Middle Initial & Last Name & Degree
Jace Wolf, PhD
Facility Name
Children's Hospital of Philadelphia - Buerger Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Hayman, AuD
Phone
215-590-7461
Email
hayman@email.chop.edu
First Name & Middle Initial & Last Name & Degree
Joy Peterson, AuD
Phone
215-590-7620
Email
petersonj@email.chop.edu
First Name & Middle Initial & Last Name & Degree
John Germiller, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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