Development and Application of A Multimodal Perceptual Evaluation and Precision Rehabilitation System in Congenital Deafness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Reliability
研究概览
简要总结
This study aims to establish a novel multimodal evaluation and precision rehabilitation system for patients with congenital hearing loss who have received hearing aids, cochlear implantation, or emerging gene therapy. The proposed system will integrate age-stratified difficulty levels, combined with a gamified interaction platform or software designed to assess and train three core perceptual domains: auditory speech perception, music perception, and spatial hearing capabilities.
详细描述
For congenital sensorineural hearing loss, the traditional treatment methods are hearing aids and cochlear implantation. In recent years, groundbreaking progress has been made in the field of gene therapy for deafness. However, existing assessment materials and tools are not fully applicable to gene therapy patients. In addition, most assessment materials also show other limitations, including a relatively single assessment dimension with minimal gamified interaction and a lack of age-stratified difficulty levels, etc., which pose challenges in objective and comprehensive evaluation, especially for younger children. There is an urgent need to redesign, optimize, and supplement current assessment tools to more accurately reflect post-treatment multidimensional perceptual function, establish a comprehensive evaluation system, and provide targeted rehabilitation guidance.
Therefore, this study aims to upgrade and develop a novel multimodal evaluation and precision rehabilitation system for patients with congenital hearing loss across different ages and various treatment types. Based on the existing assessment materials and software, the proposed system will combine the gamified method and interactive, friendly interface to construct a set of interesting and interactive measurements, integrating auditory speech, music perception, spatial hearing assessment and rehabilitation training. Patients with congenital hearing loss and healthy controls will be recruited to validate the reliability and validity of the evaluation system and the effectiveness of the rehabilitation training, providing reference for clinical application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Congenital Deafness Group: Patients with congenital hearing loss with hearing thresholds ≥65 dB who have received hearing aids, cochlear implantation, or gene therapy; Age between 1 and 35 years old, regardless of gender.
- •For Healthy Controls Group: Participants with normal hearing thresholds (≤20 dB) whose age and gender matched to the patient group.
- •Mandarin Chinese as the native language. Participants and/or their guardians must provide informed consent before the trial, voluntarily sign a written consent form, and commit to receive evaluation at specified time points.
- •Capable of effective communication with researchers under the guardian's assistance and willing to cooperate and comply with the researchers' requirements.
- •Participants and/or their guardians should have a correct understanding of the trial and appropriate expectations regarding potential benefits.
排除标准
- •Presence of other otological disorders that may interfere with the surgical outcome or interpretation of study endpoints, such as otitis media, Meniere's disease, etc.
- •Presence of other severe congenital diseases, such as congenital heart disease. Presence of severe systemic diseases or in the acute onset of diseases, such as pulmonary tuberculosis, active hepatitis B or C infection, active herpes zoster infection, pancreatitis, renal insufficiency, etc.
- •Individuals with low immunity, a history of immune deficiency or organ transplantation.
- •Individuals with a history of neurological, mental disorders, or moderate-to-severe cognitive dysfunction, such as epilepsy, dementia, autism spectrum disorders, etc.
- •Any other conditions for which the investigators consider the subject unsuitable for participation in this clinical study.
研究组 & 干预措施
Congenital Hearing Loss Group
The study will recruit patients with congenital hearing loss with hearing thresholds ≥65 dB who have received hearing aids, cochlear implantation, or gene therapy.
干预措施: Rehabilitation training (Other)
Healthy Controls Group
The study will recruit participants with normal hearing thresholds (≤20 dB) whose age and gender were matched to the patient group.Stage 1 involved an observational study for reliability and validity assessment, enrolling both healthy subjects and congenital deafness patients . Stage 2 involved an interventional study for rehabilitation training, which included congenital deafness patients .Healthy Controls Group were only enrolled in the Stage 1 for reliability and validity assessment, but not the Stage 2 for rehabilitation training.
结局指标
主要结局
Reliability
时间窗: Baseline and 1-4 weeks later.
The test-retest reliability of the evaluation system were assessed using Pearson correlation coefficient.
Validity
时间窗: Baseline
The validity of the evaluation system were assessed using Exploratory Factor Analysis, EFA and/or Confirmatory Factor Analysis, CFA.
Reliability
时间窗: Baseline
The reliability of the evaluation system were assessed using Cronbach's α coefficient .
次要结局
- Effectiveness of the Rehabilitation System(Baseline and 1-3 months after rehabilitation training.)