Non-Invasive Neurostimulation of the Vagus Nerve With the AlphaCore™ Device, for the Relief of Acute Bronchoconstriction Due to Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Safety- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this pilot study is to collect preliminary clinical data related to the safety and preliminary clinical benefits of non-invasive vagal nerve stimulation with the AlphaCore™ device for the relief of acute bronchoconstriction due to asthma.
Up to 30 subjects who meet all inclusion/exclusion criteria and consent to participate in the study may be enrolled at up to 5 investigational (study) sites. The study sites are clinic settings capable of treating any potential complications of bronchoconstriction, an acute exacerbation of asthma, and any emergencies associated with use of the investigational device.
详细描述
Subjects will be screened, consented and enrolled at the first visit. Subjects will return to the second visit where they are experiencing shortness of breath and will be treated with the alphacore. Breathing and vital signs will be measured before, during and after the stimulation. The study is concluded on the third visit, 7 days later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
alphacore
noninvasive neurostimulation of the vagus nerve
干预措施: AlphaCore (Device)
结局指标
主要结局
Safety- Number of Participants With Adverse Events
时间窗: From time subject signs the consent through the 1-week follow-up visit
Safety- number of participants with adverse events, including device-related, serious or unanticipated
次要结局
未报告次要终点