Remote Care: The Future of Cochlear Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- datalogging
研究概览
简要总结
The purpose of this study is to see if remote programming visits for cochlear implants are possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric Arm
- •English speaking patients (Parents can speak English and/or Spanish)
- •ages 1-17 years
- •current CI users with a Cochlear Americas device
- •minimum of 6-months of CI experience
- •maximum of 4 years of CI experience
- •Postlingual patients
- •English speaking patients
- •ages 18-90 years
- •current CI users with a Cochlear Americas device
- •minimum of 3-months of CI experience
- •maximum of 18-months of CI experience
排除标准
- •Patients with physical neuropathy, abnormal anatomy (e.g., cochlear malformations), severe cognitive deficits, and/or severe mental health difficulties
- •Patients who do not speak English
- •Patients who do not have access to the internet
- •Patients who do not live in Florida
- •Patients who have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
研究组 & 干预措施
Pediatric Arm
Patient ages 1-17 years who are current cochlear implant (CI) users will receive CI programming in person for the first visit and remotely for the second visit.
干预措施: remote CI programming (Other)
Adult Arm
Patient ages 18-90 years who are current cochlear implant (CI) users will receive CI programming in person for the first visit and remotely for the second visit.
干预措施: remote CI programming (Other)
结局指标
主要结局
datalogging
时间窗: up to 8 months
measured via CI programming software (hours per week)
electrode impedances
时间窗: up to 8 months
measured via CI programming software (kOhm)
auditory skills as measured by the LittleEars Questionnaire
时间窗: up to 8 months
The LittleEars auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance.
auditory skills as measured by the Auditory Skills Checklist (ASC)
时间窗: up to 8 months
ASC has a Total Score ranges from zero to 70, with higher scores indicating development of increasingly complex listening skills
hearing disability as measured by the Speech, Spatial and Qualities Hearing Scale (SSQ)
时间窗: up to 8 months
The SSQ is a a 49 item self-report test of hearing disability across three main sections and 10 pragmatic subscales. The total score ranges from zero to ten, with a lower score indicating a higher degree of hearing disability
electrically evoked compound potential values (neural response telemetry)
时间窗: up to 8 months
measured via CI programming software (mV)
stimulation levels
时间窗: up to 8 months
threshold and upper stimulation levels measured via CI programming software (clinical unit)
次要结局
- Quality of Life- CI (QoL-CI)(up to 8 months)
- Parenting Stress Index/Short Form (PSI)(up to 8 months)
- Behavior Assessment System for Children, 3rd Edition (BASC-3)(up to 8 months)
- Generalized Anxiety Disorder-7 (GAD-7)(up to 8 months)
- Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R)(up to 8 months)
- Parenting Stress-CI(up to 8 months)
- Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile)(up to 8 months)
- Patient Health Questionnaire (PHQ-8)(up to 8 months)
研究者
Meredith Holcomb
Associate Professor, Director of Cochlear Implants
University of Miami