A Usability Study of External Neuromodulation With iTEAR100 Generation 2
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Usability
研究概览
简要总结
A Usability Study of External Neuromodulation With iTEAR100 Generation 2. A study which evaluates user ability to train and access the iTEAR100 device in a telehealth environment.
详细描述
A Usability Study of External Neuromodulation With iTEAR100 Generation 2. A study which evaluates user ability to train and access the iTEAR100 device in a telehealth environment. Subjects sign a consent form and are sent a device. After downloading a mobile app, they can access the device and download a prescription. At 7 days, an official telehealth visit evaluates their success in the set up and training. At 30 days, the trial ends, A usability survey and symptom evaluation survey are used to determine success.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Able to sign English language consent form and over age 18 and reside in the U.S.
排除标准
- 未提供
研究组 & 干预措施
iTEAR100 Therapy
Treatment Arm. Assessment of usability of generation 2 connected devices
干预措施: iTEAR100 (Device)
结局指标
主要结局
Usability
时间窗: 30 days
Subjects rate the device usability similar to daily mobile applications and home devices using a scale from -3 to +3 with 0 being same as every day devices such as bank application, restaurant application, etc.
次要结局
- Adverse Events(30 days)
- Symptom Score(30 Days)
- Symptom Scores(30 days)