Clinical Trial: Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss

Brief Summary: This feasibility study evaluates whether children with unilateral, moderate to profound sensorineural hearing loss experience an improvement in speech perception, hearing in noise, localization, and quality of life with a cochlear implant as compared to an unaided listening condition.

Detailed Summary:

Unilateral hearing loss (UHL) is a term used to describe a substantial hearing loss in one ear and normal hearing in the contralateral ear. Despite normal hearing in one ear, these individuals experience reduced speech perception in noise, variable abilities on localization tasks, increased reports of hearing handicap, reduced quality of life, and often, they obtain limited or no benefit from conventional amplification. In the United States, the prevalence of UHL in children ranges from 0.03% to 3%, depending on the age of the child.

Cochlear implantation performed for children with bilateral, severe to profound deafness has significant impacts on several aspects of child development.

The practice of providing cochlear implants to children who have significant hearing loss in one ear is of great interest and is occurring with greater frequency as reported in case studies and small set clinical reports. The primary purpose of this feasibility study is to demonstrate the effectiveness of cochlear implantation in children, age 3 years 6 months to 6 years, 6 months, with moderate to profound UHL. Postoperative results will be evaluated with speech perception measures, localization tasks, hearing in noise tasks, and subjective reports.


Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome:

  • Change in percent correct in speech perception as measured with single words presented in a closed set. [ Time Frame: Speech perception will be compared baseline to 3 month post implant, baseline to 6 month post implant, baseline to 9 month post implant, baseline to 12 months post implant, baseline to 18 months post implant and baseline to 24 months post implant ]
    Closed set word identification presented by direct input to the speech processor using the Early Speech Perception (ESP)Test (Moog & Geers,1990), which is a test commonly used to assess young children with hearing loss
  • Change in percent correct in speech perception as measured with single words [ Time Frame: Speech perception will be compared baseline to 3 month post implant, baseline to 6 month post implant, baseline to 9 month post implant, baseline to 12 months post implant, baseline to 18 months post implant and baseline to 24 months post implant ]
    Open set word identification presented by direct input to the speech processor using the Consonant-Nucleus-Consonant (CNC) words (Peterson & Lehiste, 1962), which is commonly used to assess cochlear implant recipients.
  • Change in percent correct in speech perception as measured with sentences in quiet [ Time Frame: Speech perception will be compared baseline to 3 month post implant, baseline to 6 month post implant, baseline to 9 month post implant, baseline to 12 months post implant, baseline to 18 months post implant and baseline to 24 months post implant ]
    Open set word understanding in sentences assessed using the Pediatric AzBio sentence (Baby Bio) test (Spahr et al., 2014) presented by direct input to the

    Original Primary Outcome: Same as current

    Current Secondary Outcome: Change in degrees of separation in localization with the cochlear implant on versus the cochlear implant off [ Time Frame: Localization sensitivity will be measured and compared baseline to 3 months post implant, baseline to 9 months post implant, baseline to 18 months post implant and baseline to 24 months post implant ]

    Soundfield localization of 200-ms speech-shaped noise, presented from up to 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room


    Original Secondary Outcome: Same as current

    Information By: University of North Carolina, Chapel Hill

    Dates:
    Date Received: October 27, 2016
    Date Started: April 20, 2017
    Date Completion: July 2020
    Last Updated: April 20, 2017
    Last Verified: April 2017