RECRUITING

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

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Conditions

Asymmetric Hearing LossSingle-sided DeafnessUnilateral Deafnesshearing losscochlear implant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-09-20
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04793412

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * At least 4 ys of age and up to 14 yrs, 11 mos of age and able to complete all investigational procedures.
  2. * 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.
  3. * 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.
  4. * Better ear
  5. * 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.
  6. * 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.
  7. * Both ears of NH participants: PTA at .5, 1, 2, 4 kHz ≤ 25 dB HL.
  8. * 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.
  9. * 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.
  10. * 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.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

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

Principal Investigator

Jill B Firszt, PhD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine in St Louis

Study Locations (Sites)

Keck School of Medicine of the University of Southern California
Los Angeles, California, 90033
United States
Fairview Health Services
Minneapolis, Minnesota, 55454
United States
Washington University School of Medicine/St Louis Children's Hospital
Saint Louis, Missouri, 63110
United States
Hearts for Hearing
Oklahoma City, Oklahoma, 73120
United States
Children's Hospital of Philadelphia - Buerger Center
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Jill B Firszt, PhD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine in St Louis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-20
Study Completion Date2025-12

Study Record Updates

Study Start Date2021-09-20
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • hearing loss
  • cochlear implant

Additional Relevant MeSH Terms

  • Asymmetric Hearing Loss
  • Single-sided Deafness
  • Unilateral Deafness