Outcomes in Children With Pre-operative Residual Hearing

Hearing Disorders in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03379870
• Other study ID #: 17-2360
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 25, 2018
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 hearing aid alone (HA-alone) and with combined electric-acoustic stimulation (EAS). Subjects in Arm 2 will be evaluated with the CI-alone.

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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Months to 215 Months

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Disorders
• Hearing Disorders in Children
• Hearing Loss
• Hearing Loss, Sensorineural
• High Frequency Sensorineural Hearing Impairment

Intervention

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,
• 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.

Locations

Country	Name	City	State
United States	The Children's Cochlear Implant Center at UNC	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Med-El Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent correct in prosodic identification scores, comparing EAS to CI-Alone conditions in Arm 1 participants	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. Lower scores indicate a poorer outcome, and higher scores a better outcome.	12 months post-stimulation
Primary	Mean CNC word scores, comparing EAS and CI-alone conditions at 12 months post stimulation (Arm 1 to Arm 2).	The CNC word list is established as a standard test of speech perception outcomes. Results for EAS and CI-alone conditions at 12 months post stimulation will be compared (Arm 1 to Arm 2). Lower scores indicate a poorer outcome and higher scores a better outcome.	12 months post stimulation
Primary	Mean BKB-SIN SNR-50 scores, comparing EAS and CI-alone conditions at 12 months post stimulation (Arm 1 to Arm 2).	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 CI-alone conditions at 12 months post stimulation will be compared (Arm 1 to Arm 2). In this test, lower scores indicate a better outcome and higher scores a poorer outcome.	12 months post-stimulation
Secondary	Mean Pediatric SSQ scores, comparing Pre-operative and 12 month post stimulation scores in both groups.	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.	12 months post-stimulation
Secondary	Change in percent correct in single word scores in quiet, comparing pre- and post-stimulation scores in both groups	Mean single word scores in quiet, comparing scores obtained pre-operatively and in the primary post-operative listening condition in both groups. Lower scores are a poorer outcome than higher scores.	12 months post-stimulation
Secondary	Change in speech and language outcomes, comparing Pre- and post-stimulation scores in both groups.	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. Low scores are indicative of a poorer outcome, and higher scores a better outcome.	12 months post-stimulation