Cochlear-Implanted Recipient Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Cochlear
- 入组人数
- 1,518
- 试验地点
- 77
- 主要终点
- Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
研究概览
简要总结
The purpose of this study is to collect patient related benefit data following treatment for permanent hearing loss with a hearing implant from the company Cochlear over a period of 2 years post treatment.
Assessment of benefits is based on standard questionnaires of hearing ability and quality of life in general.
详细描述
The clinical investigation is designed as a prospective repeated measures longitudinal study with intra-subject controls, using a selection of subjective evaluation tools to assess patient related benefits from hearing implant treatment of permanent hearing loss.
Clinically standard self-assessment scales, threshold measures and a general hearing history profile questionnaires for the clinician and implant recipient are made available for selection through an interface to a central electronic platform.
The registry is aimed at collection of data for patients who have already made the decision together with their implant centre clinician for an implant device from the company Cochlear.
Patients are approached for registry participation following implant by the caring clinician on a consecutive and voluntary basis and on condition of signing the patient informed consent.
Monitoring of data entry is included through automated reminders via e-platform and through inherent audit trail.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-lingually deafened adults and adolescents who are newly implanted AND prior to first switch-on of their external device
- •Unilateral, bilateral simultaneous recipients of any implant device(s) available with market approval from the company Cochlear®
- •Children 10 years or older and in accordance with local regulations and product labelling
- •Mentally capable to respond to self-administered assessment scales
- •Willingness to participate and sign the Patient Informed Consent form
排除标准
- •Individuals excluded from participation in a registry according to national or local regulations
结局指标
主要结局
Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
时间窗: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years
A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from baseline to post-implant at 3 years is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
时间窗: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years
A scale from 0 to 10 is used, where 0 represents "can not hear at all" and 10 "hear perfectly". The change from baseline to post-implant at 3 years is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
次要结局
- Unaided Hearing Thresholds(post-implant at 2 years)