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Trial record 2 of 3 for:    pediatric cochlear implant | Unilateral Deafness

Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss (CIPUHL)

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ClinicalTrials.gov Identifier: NCT02963974
Recruitment Status : Recruiting
First Posted : November 15, 2016
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
Med-El Corporation
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Hearing Loss, Unilateral Device: Cochlear implant Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cochlear Implant
Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss
Device: Cochlear implant
Implantation
Other Names:
  • MED-EL Cochlear Implant
  • MED-EL Synchrony with FLEX 28 array
  • MED-EL Synchrony with FLEX 24 array




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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 speech processor and/or in the sound field. This test is commonly used to assess pediatric cochlear implant recipients.

  4. Change in percent correct in speech perception as measured with sentences in noise [ 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 sentences (Baby Bio) test (Spahr et al., 2014) presented in the sound field with noise in the background. This test is commonly used to assess pediatric cochlear implant recipients.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Change in assessment of quality of life with the cochlear implant as measured by the Speech Spatial Qualities Questionnaire [ Time Frame: Administered at baseline and compared to score at 3 months post implant, 6 months post implant, 9 months post implant, 12 months post implant, 18 months post implant and 24 months post implant ]
    The Speech Spatial Qualities Questionnaire requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 (Not at all) to 10 (Perfectly). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. The SSQ questionnaire assesses performance in three domains, hearing speech in quiet and noise environments (9 items), spatial or directional hearing (5 items) and sound qualities (8 items), which address sound segregation and listening effort. Domain scores represent an average of item ratings. A modified version of this test will be used.

  2. Change in assessment of quality of life with the cochlear implant as measured by the Peds QL [ Time Frame: Administered at baseline and compared to score at 3 months post implant, 6 months post implant, 9 months post implant, 12 months post implant, 18 months post implant and 24 months post implant ]
    PedsQL Multidimensional fatigue scale (Varni, Limbers & Burwinkle, 2007) is a validated scale for determining fatigue in young children, including general fatigue, sleep/rest fatigue and cognitive fatigue. Scores from this test have been previously demonstrated to be substantially affected by hearing loss in children.

  3. Change in assessment of hearing related behaviors with the cochlear implant as measured by the Bern SSD Questionnaire [ Time Frame: Administered at baseline and compared to score at 3 months post implant, 6 months post implant, 9 months post implant, 12 months post implant, 18 months post implant and 24 months post implant ]
    Bern SSD Questionnaire, (Kompis, Pfiffner, Krebs & Caversaccio , 2011) is a 10-item questionnaire used for rating the subjectively perceived benefit of a hearing technology designed to be used for persons with UHL. A modified version of this test that can be completed by a parent will be used.



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Ages Eligible for Study:   42 Months to 78 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

i) Inclusion Criteria

  1. Unilateral moderate-to-profound sensorineural hearing loss.

    1. Unaided residual hearing thresholds that yield a PTA at frequencies 500Hz, 1K Hz and 2K Hz of ≥70 dB HL in the ear to be implanted. It is possible that subjects may have hearing at other frequencies not included in this average.
    2. Hearing thresholds in the contralateral ear of ≤25 dB HL
  2. Between 3 years, 6 mos and 6 years, 6 mos of age at implantation.
  3. Anatomically normal cochlear nerve
  4. Cochlear anatomy that is amenable to cochlear implantation as evaluated by imaging (modality at the physician's discretion) including:

    1. Normal cochlear anatomy or
    2. Incomplete Partition Type II (IP2) with or without Enlarged Vestibular Aqueduct (EVA) or
    3. EVA with normal partitioning
  5. No evidence of progressive hearing loss.
  6. Willing to undergo 4 week hearing aid trial as warranted based on achieving desired audibility when fitted via real ear DSL method.
  7. Aided word recognition in the ear to be implanted of 30% or less as measured with CNC words (50-word list)

    1. When listening with an appropriately fit hearing aid and masking applied to the contralateral ear (Turner, 2004).
    2. Aided testing will be conducted in a sound-proof booth with the participant seated 1 meter from the sound source, facing 0° azimuth. Recorded materials will be presented at 60 dB SPL.
    3. The hearing aid output will be measured using DSL targets.
  8. Realistic parental expectations: a verbal acknowledgement of the potential benefits and risks, and postoperative variation in performance. For instance, cochlear implantation will not restore normal hearing.
  9. Willing to obtain recommended meningitis vaccinations per CDC recommendations.

(9) Development and cognition within the normal range as measured by the Leiter-R test of nonverbal intelligence and cognitive abilities and the Bracken Basic Concept Scale -Revised.

(10) Parental commitment to study parameters including being able and willing to participate in evaluation schedule, involvement in prescribed therapy, and travel to investigational site and study-related activities.

ii) Exclusion Criteria

  1. English is not primary language of the home

    1. Speech perception materials are presented in English
    2. Parental questionnaires are administered in English
  2. Conductive hearing loss in either ear
  3. Compromised auditory nerve
  4. Ossification of the cochlea
  5. Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)
  6. History of condition that contraindicates middle or inner ear surgery or anesthesia (i.e. otitis media refractory to treatment)
  7. Case of sudden sensorineural hearing loss that has not been first evaluated by a physician

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): NCT02963974


Contacts
Contact: Kevin D Brown, MD, PhD 919-843-4820 kevin_d_brown@med.unc.edu
Contact: Lisa Park, AuD 919-419-1449 lisa_park@med.unc.edu

Locations
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7600
Contact: Kevin D Brown, MD    919-966-6484    kevin_d_brown@med.unc.edu   
Contact: Lisa Park, AuD    919 419-1449    lisa_park@med.unc.edu   
Principal Investigator: Kevin D Brown, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Med-El Corporation
Investigators
Principal Investigator: Kevin D Brown, MD, PhD University of North Carolina, Chapel Hill

Publications:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02963974     History of Changes
Other Study ID Numbers: 15-3350
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
cochlear implant

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Unilateral
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms