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Completed

NCT Number: NCT03379870

Outcomes in Children With Pre-operative Residual Hearing

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 (EAS Arm; electric-acoustic stimulation) 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 (FES Arm; full-electric stimulation) 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 the EAS Arm will be evaluated with combined electric-acoustic stimulation (EAS). Subjects in FES Arm will be evaluated with FES alone.

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Key information

Conditions

High Frequency Sensorineural Hearing Impairment Ear Diseases Hearing Disorders Hearing Disorders in Children Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

60 month–215 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Cochlear Implant Center at UNC

Durham, North Carolina, 27713-6102, United States

About this study

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 or SONNET 2 EAS device using combined acoustic and electric stimulation. Those who have not maintained low frequency hearing will be fit with a SONNET EAS or SONNET 2 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 5 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.
  • Realistic parental/patient expectations.
  • Language skills judged to be adequate enough to perform study tasks.

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
  • 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.

Treatment and study plan

Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting

Device

Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,

Other names: MED-EL SONNET EAS, MED-EL SONNET 2 EAS

Electric Acoustic Speech Processor: Full-electric stimulation fitting

Device

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 names: MED-EL SONNET EAS, MED-EL SONNET 2 EAS

Primary outcomes

  1. Mean CNC Word Scores

    Time frame: 12 months post stimulation

    The Consonant Nucleus Consonant (CNC) word list is established as a standard test of speech perception outcomes. Results for EAS and FES Arms at 12 months post stimulation will be compared. Lower scores indicate a poorer outcome and higher scores a better outcome. Scale 0 - 100%

  2. Mean BKB-SIN SNR-50 Scores

    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. Results for EAS and FES listeners at 12 months post stimulation will be compared. In this test, lower scores indicate a better outcome and higher scores a poorer outcome. Scores range from -6 dB to +21 dB.

Secondary outcomes

  1. Mean Pediatric SSQ Scores

    Time frame: Baseline, 12 months post-stimulation

    The Speech, Spatial, and Qualities of Hearing (SSQ) Scale 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. Each item is rated on a 11-point scale, with 0 as the lowest possible performance and 10 as the highest. Domain scores represent an average of item ratings. There is a version for children that will be used for this study. Lower scores indicate a poorer outcome, and higher scores a better outcome.

  2. Receptive Language Scores

    Time frame: 12 months post-stimulation

    Mean receptive language scores as measured by the Oral and Written Language Scales, 2nd edition (OWLS II), comparing pre-operative scores to the 12 month test point for both groups. These tests are normed and reported as scaled scores. T-Scores scores will be compared. Low scores are indicative of a poorer outcome, and higher scores a better outcome. A scores of 100 indicated the population mean with a standard deviation of 15. A score of 85 or poorer is indicative of a receptive language delay.

  3. Articulation Scores

    Time frame: 12 months post-stimulation

    Mean articulation scores as measured by the Goldman-Fristoe Test of Articulation, 3rd edition (GFTA3), comparing pre-operative scores to the 12 month test point for both groups. These tests are normed and reported as scaled scores. T-Scores scores will be compared. Low scores are indicative of a poorer outcome, and higher scores a better outcome. A score of 100 indicates the population mean with a standard deviation of 15. A score of 85 or poorer is indicative of a articulation delay.

  4. Expressive Language Scores

    Time frame: 12 months post-stimulation

    Mean expressive language scores as measured by the Oral and Written Language Scales, 2nd edition (OWLS II), comparing pre-operative scores to the 12 month test point for both groups. These tests are normed and reported as scaled scores. T-Scores scores will be compared. Low scores are indicative of a poorer outcome, and higher scores a better outcome. A score of 100 indicates the population mean with a standard deviation of 15. A score of 85 or poorer is indicative of an expressive language delay.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Med-El Corporation

Registry information

Official study title

Outcomes in Children With Cochlear Implants and Pre-Operative Residual Hearing: Electric Only and Electric-Acoustic Stimulation

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Dec 20, 2017
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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