NCT04884607已完成不适用
Electrocardiogram Measurement and Subthreshold Low-level Autonomic Nerve Stimulation Using External Auditory Canal Electrodes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Heart rate variability
研究概览
简要总结
- Purpose of the study This study aimed to investigate electrocardiogram measurement and subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes among healthy adult participants
- Study design Prospective, single-center, interventional, single-arm design
- Study participants A total of 12 healthy adult participants without cardiovascular diseases will be recruited.
- Study methods
- Participant enrollment Study participants will be recruited by advertisement posters announced at the lobby of the hospital
- Evaluation of electrocardiogram measurement from external auditory canal electrodes Participants are required to attach specially designed external auditory canal electrodes to their both ears to record electrocardiogram. Both electrocardiogram from the precordium and the ear would be simultaneously recorded and compared.
- Evaluation of low-level autonomic nerve stimulation using external auditory canal Using the electrodes described above, Arnold's nerve will be stimulated with low-level electric impulses using TENS device. During and after the stimulation, heart rate variability will be measured to investigate the impact of nerve stimulation on autonomic function modulation on the heart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults without cardiovascular diseases
- •Aged 20 years or more with Informed consent
排除标准
- •Patients with autonomic disorder, cardiovascular drug prescriptions, cardiovascular diseases, diabetes, or with cardiac implantable electronic devices
- •Patients with abnormalities at both external auditory canals and ears
结局指标
主要结局
Heart rate variability
时间窗: Through study completion, an average of within 1 day
Selected parameters of heart rate variability
次要结局
未报告次要终点
研究者
Seil Oh
Professor
Seoul National University Hospital
研究点 (2)
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