Comprehensive Follow-up and Evaluation for Cochlear Implant Patients for All Ages
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Evaluation of Auditory Function
研究概览
简要总结
This study aims to assess hearing and speech perception, as well as quality of life, in deaf patients of all ages before and after cochlear implantation, and to explore differences across age groups and treatment subtypes, thereby providing evidence for personalized hearing and speech rehabilitation.
详细描述
The study aims to conduct a comprehensive evaluation of auditory and speech perception abilities, as well as overall quality of life, in patients with hearing loss across all age groups undergoing cochlear implantation. By comparing pre- and post-operative outcomes, the study will investigate how different age cohorts and subtype groups respond to cochlear implantation treatment. The findings are expected to provide critical evidence to guide the development of individualized auditory and speech rehabilitation strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe or greater hearing loss (≥65 dB) scheduled to receive cochlear implant (CI) treatment.
- •No restrictions on age or gender.
- •Native language is Mandarin Chinese.
- •The subject and/or their legal guardian must provide informed consent prior to the study, voluntarily sign a written informed consent form, and be willing to undergo follow-up assessments at the specified time points.
- •Ability to communicate effectively with the researcher with the help of a guardian and comply with the researcher's requirements. For young children without mature language skills, ability to cooperate with the help of a guardian.
- •The subject's guardian has a correct understanding of the trial and realistic expectations of potential benefits.
排除标准
- •Presence of other severe diseases unsuitable for cochlear implantation surgery.
- •Significant psychological problems or mood disorders (e.g., notable anxiety, depression, or behavioral disorders) that would preclude cooperation with training and follow-up.
- •Neurological diseases (e.g., epilepsy, cerebral palsy) that may affect auditory processing ability.
- •Concurrent participation in other interventional studies involving drugs or behavioral interventions that may affect auditory rehabilitation during the study period.
- •Any other condition considered by the investigator to make the subject unsuitable for participation in this clinical study.
研究组 & 干预措施
Cochlear Implant Recipients
干预措施: Cochlear Implantation (Procedure)
结局指标
主要结局
Evaluation of Auditory Function
时间窗: From enrollment until the end of the 5-year follow-up. Assessments are conducted preoperatively, at device activation, and post-activation at 4 weeks, 13 weeks, 26 weeks, 52 weeks, 2 years, 3 years, and 5 years.
A comprehensive assessment of auditory sensitivity and daily listening abilities. Objective measures include electrophysiological tests (Auditory Brainstem Response, ABR; Auditory Steady-State Response, ASSR) for threshold estimation, particularly in non-communicative subjects. Behavioral audiometry and sound-field testing determine hearing thresholds in dB HL. Distortion Product Otoacoustic Emissions (DPOAE) assess cochlear outer hair cell function. Subjective auditory performance is evaluated using standardized questionnaires: the Categories of Auditory Performance (CAP, range 0-7, higher is better).The Parents' Evaluation of Aural/oral performance of Children (PEACH), consists of 12 core items, each rated on a 5-point scale from 0 to 4. Total scores are calculated to a percentage, ranging from 0% to 100%. A higher percent indicates better auditory and communication performance.
次要结局
- Evaluation of Speech Function(From enrollment until the end of the 5-year follow-up. Assessments are conducted preoperatively, at device activation, and post-activation at 4 weeks, 13 weeks, 26 weeks, 52 weeks, 2 years, 3 years, and 5 years.)
- Assessment of Psychosocial and Functional Outcomes(From enrollment until the end of the 5-year follow-up. Assessments are conducted preoperatively, at device activation, and post-activation at 4 weeks, 13 weeks, 26 weeks, 52 weeks, 2 years, 3 years, and 5 years.)