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Outcomes in Children With Pre-operative Residual Hearing

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ClinicalTrials.gov Identifier: NCT03379870
Recruitment Status : Enrolling by invitation
First Posted : December 20, 2017
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
Med-El Corporation
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

Purpose: Routine clinical care and pilot study data has shown evidence of postoperative hearing preservation in pediatric cochlear implant (CI) recipients. The primary aim of this study is to investigate speech perception performance in pediatric CI recipients with functional pre-operative hearing.

Participants: Two cohorts of CI recipients aged 6 through 17 years who had pre-operative low frequency residual hearing. Subjects in Arm 1 will present with a post-operative low frequency pure tone average (125, 250, and 500 Hz) of ≤ 75 dB HL, and those in Arm 2 will present with a post-operative low frequency pure tone average (LFPTA) that exceeds 75 dB HL.

Procedures (methods): Subjects will complete speech perception and quality of life testing during post-operative intervals. Subjects in Arm 1 will be evaluated with the cochlear implant alone (CI-alone) and with combined electric-acoustic stimulation (EAS). Subjects in Arm 2 will be evaluated with the CI-alone.


Condition or disease Intervention/treatment Phase
High Frequency Sensorineural Hearing Impairment Hearing Disorders in Children Device: Electric Acoustic Speech Processor: EAS fitting Device: Electric Acoustic Speech Processor: Electric only fitting Not Applicable

Detailed Description:

As children with more residual hearing are receiving cochlear implants (CIs), there is an opportunity to preserve that hearing and provide combined electric and acoustic stimulation (EAS). The primary aim of this study is to investigate speech perception performance in pediatric CI recipients with functional pre-operative hearing. Specifically, the investigators intend to compare speech understanding using EAS and traditional full electric stimulation.

While hearing preservation rates are good, they are not guaranteed. Children with progressive hearing loss may continue to lose hearing, even if they maintain some residual hearing immediately after surgery. As a secondary aim, the investigators intend to study outcomes in children who do not maintain residual hearing and are fit with traditional CI programming methods. Children with more residual hearing are being implanted, and this study design allows validation of outcomes in both populations.

Subject enrollment will occur on the initial stimulation date. Those who have maintained a low frequency hearing average of 75 dB HL or better will be fit with a SONNET EAS device using combined acoustic and electric stimulation. Those who have not maintained low frequency hearing will be fit with a SONNET EAS device using electric stimulation only. Subjects will be followed at regular intervals throughout the year duration of the study and will be tested on measures of speech understanding in quiet, speech understanding in noise, quality of life, and discrimination of prosody or pitch changes.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcomes in Children With Cochlear Implants and Pre-Operative Residual Hearing: Electric Only and Electric-Acoustic Stimulation
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1

Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL.

Electric Acoustic Speech Processor: EAS fitting. They will be evaluated in the EAS condition and a traditional fully electric condition.

Device: Electric Acoustic Speech Processor: EAS fitting
Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,
Other Name: MED-EL SONNET EAS

Device: Electric Acoustic Speech Processor: Electric only fitting
Electric Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or poorer and pre-operative low frequency hearing averages of 75 dB HL or better.
Other Name: MED-EL SONNET EAS

Experimental: Arm 2

Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of > 75 dB HL.

Electric Acoustic Speech Processor: Electric only fitting They will be evaluated in the traditional fully electric condition only.

Device: Electric Acoustic Speech Processor: Electric only fitting
Electric Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or poorer and pre-operative low frequency hearing averages of 75 dB HL or better.
Other Name: MED-EL SONNET EAS




Primary Outcome Measures :
  1. Change in percent correct in single word scores in quiet, comparing EAS and CI-alone conditions in Arm 1 participants. [ Time Frame: 12 months post stimulation ]
    Mean single word scores in quiet, comparing scores obtained in the EAS and traditional electric conditions.

  2. Change in mean SNR-50 for sentences in noise, comparing EAS and CI-alone conditions in Arm 1 participants. [ Time Frame: 12 months post-stimulation ]
    Sentences and babble will be presented from the same speaker. An average score known as the SNR-50 will be obtained in both conditions. The SNR-50 score is an estimate of the signal-to-noise ratio associated with 50% correct based on word-level scoring.


Secondary Outcome Measures :
  1. Change in Quality of Life, comparing Pre- and post-stimulation scores in both groups. [ Time Frame: 12 months post-stimulation ]
    The PedsQL Multidimensional fatigue scale is a validated 5-point Likert scale for determining fatigue in young children. The subscales are general fatigue, sleep/rest fatigue, and cognitive fatigue. Children and their parents rate fatigue on a scale of 0-4, with 0 being no difficulty and 4 being the highest difficulty. Items are reversed scored and linearly transformed to a 0-100 scale so that higher scores indicate lower problems. A Total Mean score is computed across dimensions.

  2. Change in percent correct in single word scores in quiet, comparing pre- and post-stimulation scores in both groups [ Time Frame: 12 months post-stimulation ]
    Mean single word scores in quiet, comparing scores obtained pre-operatively and in the primary post-operative listening condition in both groups.

  3. Change in speech and language outcomes, comparing Pre- and post-stimulation scores in both groups. [ Time Frame: 12 months post-stimulation ]
    Mean articulation, expressive, and receptive language scores, comparing pre-operative scores to the 12 month test point for both groups. These tests are normed. Scaled scores will be compared.

  4. Change in percent correct in prosodic identification scores, comparing EAS to CI-Alone conditions in Arm 1 participants [ Time Frame: 12 months post-stimulation ]
    The Question/Answer Task identifies how well a child can perceive changes in pitch that change the meaning of a sentence. Percent correct scores will be obtained and compared.



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Ages Eligible for Study:   72 Months to 215 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 6 through 17 years
  • Spoken English as the primary language (speech perception testing conducted in English).
  • Recipient of a MED-EL SYNCHRONY Cochlear Implant device.
  • Pre-operative LFPTA of ≤ 75 dB HL.
  • Willing and able to participate in study procedures.
  • Cognition within normal limits as measured by the Leiter-R.
  • Realistic parental/patient expectations.
  • Language skills no more than two standard deviations below the mean per the OWLS II as measured within the 6 months prior to enrollment.

Exclusion Criteria:

  • Inability to perform open set speech perception due to oral motor delays.
  • Inability to perform test battery due to behavior or cognitive impairment as measured by the Leiter-R.
  • Unwilling or unable to participate in study procedures.
  • Cochlear nerve deficiency.
  • Anatomical considerations that necessitated surgical modifications such as ossification, incomplete insertion, or placement in scala vestibuli.

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): NCT03379870


Locations
United States, North Carolina
The Children's Cochlear Implant Center at UNC
Durham, North Carolina, United States, 27713-6102
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Med-El Corporation
Investigators
Principal Investigator: Lisa Park, AuD University of North Carolina, Chapel Hill

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03379870     History of Changes
Other Study ID Numbers: 17-2360
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 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
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of North Carolina, Chapel Hill:
cochlear implant
electric acoustic stimulation
EAS
hearing loss
pediatric

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