Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Post-implant bimodal vs better ear alone speech understanding in noise
研究概览
简要总结
This is a two-phase study that compares performance growth pre-implant with current hearing aid (HA) technology versus post-implant with a cochlear implant (CI) in children with either asymmetric hearing loss (AHL) or single-sided deafness (SSD). Post-implant performance with a CI alone is expected to outperform pre-implant performance with a HA. The study also evaluates the effectiveness of bimodal hearing defined as a CI in the poor ear and a HA in the better ear for AHL or a CI in the poor ear and normal hearing in the better ear for SSD compared to pre-implant performance. The study examines factors contributing to CI outcomes.
详细描述
The study is conducted as a multicenter, prospective, two-phase clinical trial, evaluating the efficacy and safety of cochlear implantation in children with asymmetric hearing loss (AHL) or single-sided deafness (SSD). A hearing aid (HA) phase occurs over a minimum of 4 mos prior to obtaining a cochlear implant (CI). A CI phase occurs over the 15-month period after initial activation of the CI. The AHL/SSD groups are tested for change in performance pre- to post-implant. Investigators also collect longitudinal data over 12 months (matching the 3 to 15 month post-implant timeframe) from normal hearing (NH) participants to provide additional information about outcome trajectory due to development alone. The NH participants are matched to AHL/SSD participants on age, gender and parent education. Post-implant performance with a CI alone is expected to outperform pre-implant performance with a HA. The study evaluates the effectiveness of bimodal hearing defined as a CI in the poor ear and a HA in the better ear for AHL or a CI in the poor ear and normal hearing in the better ear for SSD compared to pre-implant performance. The study examines factors contributing to CI outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 4 ys of age and up to 14 yrs, 11 mos of age and able to complete all investigational procedures.
- •Parents and child fluent in English. Parents desire bilateral hearing for their child, are willing to comply with study requirements, including the pre-implant HA phase, and are able to provide informed consent.
- •Poor ear (AHL/SSD): PTA at .5, 1, 2 kHz > 70 dB HL; Aided CNC word recognition score at 60 dB SPL < 40%; SPHL duration ≥ 6 mos and ≤ 10 yrs at time of CI surgery; If > 5 yrs of age, evidence of non-congenital SPHL onset (e.g., passed newborn hearing screening); If ≤ 5 yrs of age, no restrictions on SPHL onset.
- •Better ear
- •AHL: PTA at .5, 1, 2, 4 kHz > 25 and ≤ 60 dB HL; Aided CNC word score at 60 dB SPL ≥ 55%; Currently using a HA; Stable hearing for the past 6-mo period. "Stable" is defined as thresholds that have not declined by more than 20 dB at three or more octave-interval audiometric frequencies.
- •SSD: PTA at .5, 1, 2, 4 kHz ≤ 25 dB HL; CNC word score at 60 dB SPL ≥ 70%; Stable hearing for the past 6-mo period.
- •Both ears of NH participants: PTA at .5, 1, 2, 4 kHz ≤ 25 dB HL.
- •To continue with cochlear implantation and into the CI phase of the study: Indication, via imaging, of a normal cochlear nerve and of cochlear anatomy in the ear to be implanted that allows full insertion of the electrode array. Imaging modality is at the discretion of the surgeon. In addition, better ear hearing must be stable throughout the HA phase.
排除标准
- •for AHL/SSD Participants:
- •Medical condition that contraindicates surgery; Actively using an implantable device in the ear to be implanted; Inability to complete study procedures; Unrealistic expectations related to the benefits and limitations of implantation; Unwillingness or inability to comply with all investigational requirements.
- •Exclusions for cochlear implantation and the CI phase of the study: Cochlear malformation or obstruction that would preclude full insertion of the electrode array in the ear to be implanted; Abnormal cochlear nerve in the ear to be implanted; Hearing loss of neural or central origin.
研究组 & 干预措施
AHL/SSD
Children with asymmetric hearing loss or single-sided deafness
干预措施: Cochlear Implant (Device)
结局指标
主要结局
Post-implant bimodal vs better ear alone speech understanding in noise
时间窗: 15 months post-implant
Post-implant speech reception thresholds (SRTs) for understanding words in noise in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) compared to the better ear alone condition.
Change in Poor ear alone word recognition in quiet from Pre-Implant to 12 months post-implant
时间窗: Pre-Implant and 12 months post-implant
Poor ear alone CNC monosyllabic word recognition in quiet with the CI alone compared to pre-implant with a HA.
Change in Bimodal speech understanding in noise from Pre-Implant to 15 months post-implant
时间窗: Pre-implant and 15 months post-implant
Speech reception thresholds (SRTs) for understanding words in noise in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) post-implant compared to the pre-implant best aided condition.
Change in pre-implant trajectory of Bimodal speech understanding in noise over time to post-implant trajectory over time
时间窗: 5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits
The trajectory of speech reception thresholds (SRT) for understanding noise throughout the CI Phase (5 visits post-implant) in the bimodal condition is compared to the trajectory throughout the HA Phase (5 visits pre-implant) in the best aided condition.
次要结局
- Post-implant bimodal vs better ear alone soft speech understanding(12 months post-implant)
- Change in Bimodal sound localization from Pre-Implant to 15 months post-implant(Pre-implant and 15 months post-implant)
- Post-implant bimodal vs better ear alone sound localization(15 months post-implant)
- Change in Poor ear alone audibility from Pre-Implant to 12 months post-implant(Pre-implant and 12 months post-implant)
- Change in Bimodal soft speech understanding from Pre-Implant to 12 months post-implant(Pre-implant and 12 months post-implant)
- Change in HEAR-QL ratings from Pre-Implant to 15 months post-implant(Pre-implant and 15 months post-implant)
- Change in PedsQL-MFS ratings from Pre-Implant to 15 months post-implant(Pre-implant and 15 months post-implant)
- Change in SSQ ratings from Pre-Implant to 15 months post-implant(Pre-implant and 15 months post-implant)