A Single-Center, Single-Arm Exploratory Study to Evaluate the Impact of Multimodal Acoustic Therapy (MAT) on Objective and Subjective Auditory Perception During a 12-Week Intervention and a 12-Week Follow-Up in Pediatric and Adolescent Cochlear Implant Users
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Melody Contour Identification (MCI)
概览
简要总结
This exploratory, single-center, single-arm study investigates the impact of a 12-week Multimodal Acoustic Therapy (MAT) intervention followed by a 12-week follow-up period on both objective and subjective auditory perception in pediatric cochlear implant users.
详细描述
Duration of study period (per participant): 24 weeks, including a 12-week intervention and a 12-week online follow-up.
Participants will use the Multimodal Acoustic Therapy (MAT) mobile application at home for 12 weeks to improve music and speech perception.
Participants will visit the site twice (baseline and post-intervention), while all other evaluations, including follow-up, will be conducted online.
The first on-site visit is mainly to on-board participants and to train them for accurate use of the intervention.
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
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with cochlear implants
- •Korean patients aged 10 to 19 years
- •Capable of using a smartphone
- •Scored ≤80% on MCI pre-assessment
- •Voluntarily agreed to participate in this study
排除标准
- •Has systemic medical conditions (e.g., cancer, stroke) that limit daily functioning
- •Has intellectual disability, congenital malformation, or other neurological disorders affecting language or cognitive abilities
- •Has diagnosed emotional disorders such as depression or anxiety
- •Primarily uses sign language for daily communication
- •Has undergone cochlear implant revision surgery
- •Has prior experience with the investigational auditory rehabilitation application used in this study
结局指标
主要结局
Melody Contour Identification (MCI)
时间窗: 12 weeks
Participants complete a melody contour identification task in which they listen to brief melodic sequences and select the contour pattern (e.g., rising, falling, flat). Performance is quantified as the percentage of correctly identified contours (% correct). Higher scores indicate better melody contour perception.
次要结局
- Music-Related Quality of Life (MuRQoL)(12 weeks)
- Parents' Evaluation of Aural/Oral Performance of Children (PEACH)(12 weeks)
- Quality of Life - Cochlear Implants (Parent-Proxy Report)(12 weeks)
- Emotional Prosody Perception Test (EPP)(12 weeks)
- Monosyllabic Word Test(4 weeks)
- Sentence Test in Quiet(4 weeks)
- Speech test in Noise(4 weeks)
研究者
Sang-Yeon Lee
Assistant Professor
Seoul National University Hospital