Assessing the Effect of Computer-based Auditory Training on Adult Cochlear Implant Speech and Quality-of-life Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Cochlear Implant Quality of Life-35 Profile
研究概览
简要总结
The purpose of this study is to compare the effectiveness of a free computer-based auditory training program, Sound Success (Advanced Bionics, Valencia, CA), with the current standard of care of patient-directed auditory training in improving common measures of speech recognition and cochlear implant (CI) specific quality-of-life in new adult CI recipients in their first year post-activation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with a diagnosis of bilateral moderate-to-profound sensorineural hearing loss who are undergoing unilateral or simultaneous bilateral cochlear implantation at the Mayo Clinic in Rochester MN.
排除标准
- •Patients undergoing revision implantation, completion bilateral cochlear implantation, or implantation for unilateral deafness will be excluded from enrollment
- •Patients unable or unwilling to use a computer or similar device will be excluded from enrollment.
- •Patients will be excluded if they speak a language not supported by the Sound Success platform. Sound Success is available in English, Spanish, French, Italian, Dutch, Polish, and Danish.
研究组 & 干预措施
Control Group
干预措施: Standard of Care (Behavioral)
Experimental Group
干预措施: Sound Success (Behavioral)
结局指标
主要结局
Change in Cochlear Implant Quality of Life-35 Profile
时间窗: Baseline, 3 months, 6 months, 12 months
The Cochlear Implant Quality of Life-35 (CIQOL-35) Profile is a patient reported questiornaire that assesses the functional abilities of adult cochlear implant recipients within 6 domains: communication, assessing communication ability in different circumstances; emotional, assessing the impact of hearing on emotional well-being; entertainment, assessing the ability to enjoy television, radio, and music; environmental, assessing the ability to distinguish and localize environmental sounds; listening effort, assessing effort and fatigue associated with receptive communication; and social, assessing the ability to interact and enjoy interaction with groups. Scores are calculated for each domain and ranged from 0 (poorest Quality of Life) to 100 (highest Quality of Life).
次要结局
未报告次要终点
研究者
James R. Dornhoffer
Principal Investigator
Mayo Clinic