RECRUITING

Combined Electric and Acoustic Hearing (EAS) in Children and Adults

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

Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Improvements in surgery and electrodes have results in an increased number of adults and children who have residual hearing and can benefit from electric and acoustic hearing in the same ear. This is called Electric Acoustic Stimulation (EAS). Many studies have shown that adult EAS users show significant benefits for speech understanding in noise and spatial hearing tasks as compared to a CI paired only with a contralateral HA. Even though this type of hearing is becoming more common, there is limited research on how it can be beneficial to children with CIs. The benefits of this study are a greater understanding of the participant's speech understanding, binaural processing, and spatial hearing. The results will help audiologists and researcher better understand how cochlear implants work, specifically when using electric and acoustic hearing in the same ear.

Official Title

Binaural Cue Sensitivity in Children and Adults With Combined Electric and Acoustic Stimulation

Quick Facts

Study Start:2022-12-05
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05923203

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:5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Children aged 5 to 17 years of age with either normal hearing (n=40) or at least 1 cochlear implant (CI) and binaural low-frequency acoustic hearing (n=40); adults aged 18+ years with either normal hearing (n=40) or at least 1 CI and binaural low-frequency acoustic hearing (n=40).
  2. 2. Experimental participants must have at least one CI and bilateral mild to severe sensorineural hearing loss For CI participants, audiometric thresholds in the non-CI ear must be consistent with at least a mild sensorineural hearing loss; that is, the investigators will not be enrolling participants with single-sided deafness (SSD) For CI participants, unaided audiometric thresholds must be less than or equal to 80 dB HL for 125 and 250 Hz, in both ears.
  3. 3. Nonverbal cognitive abilities within the typical range for all participants; adult participants must also pass cognitive screening via Montreal Cognitive Assessment (MoCA or HI-MoCA).
  4. 4. No confounding diagnosis such as autism, auditory neuropathy, neurological disorder, or general cognitive impairment.
  5. 5. Willingness to use EAS technology in the implanted ear(s) to be verified via data logging from cochlear implant and hearing aid software.
  1. 1. Nonverbal intelligence standard score \< 85 (for any participant).
  2. 2. MoCA or HI-MoCA score \< 26 for adult participants.

Contacts and Locations

Study Contact

Linsey Sunderhaus, AuD
CONTACT
615-936-5000
linsey.sunderhaus@vumc.org
Jonathan Neukam, AuD
CONTACT
615-936-5000
jd.neukam@vumc.org

Principal Investigator

Rene H Gifford, PhD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
University Of Texas at Austin
Austin, Texas, 78712
United States
University Of Wisconsin Madison
Madison, Wisconsin, 53706
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Rene H Gifford, PhD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

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 Date2022-12-05
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2022-12-05
Study Completion Date2028-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Cochlear Implant
  • Hearing Loss