Outcomes in Children With Cochlear Implants and Pre-Operative Residual Hearing: Electric Only and Electric-Acoustic Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Mean CNC Word Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Months 至 215 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Mean CNC Word Scores
时间窗: 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%
Mean BKB-SIN SNR-50 Scores
时间窗: 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.
次要结局
- Articulation Scores(12 months post-stimulation)
- Mean Pediatric SSQ Scores(Baseline, 12 months post-stimulation)
- Receptive Language Scores(12 months post-stimulation)
- Expressive Language Scores(12 months post-stimulation)