Effects of Trigeminal Neurostimulation on Heart Rate Variability: Comparing Cutaneous (Tragus) and Tongue (Antero-Dorsal Mucosa) Stimulation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes on Root mean square standard deviation (RMSSD) parameter
研究概览
简要总结
this study wants to analyse the effect of trigeminal stimulation on Heart rate Variability. There are going to be two groups, in the test group it will be administered stimulation of the tongue with TENS, while in the control goup TENS will be administered at tragus level.
详细描述
This study analyses the effect of trigeminal stimulation with TENS on Heart rate variability (HRV). A new intraoral device will be administered on the dorsal surface of the tongue for TENS stimulation in the test group. The RMSSD, LF, HF and LF/HF will be monitered by photoplethysmographic wave. the results obtained with tongue stimulation will be compared with the results obtained in the control group, where it will be administered TENS stimulation at the tragus level. This work sought to assess whether there is a difference in HRV in relation to the site of application of dental ULFTENS (tragus vs tongue).
If effective in reducing the activity of arousal circuits, this tongue-level stimulation technique could have new clinical applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy Women
- •Age 18-30 years
排除标准
- •presence of acute and/or chronic cardio-circulatory and respiratory disorders
- •metabolic and autonomic system disorders
- •intake of excitatory or inhibiting substances of the peripheral and central nervous system
- •presence of generalised anxiety and/or panic attacks or mood disorders.
研究组 & 干预措施
Tragus group
patients in this group will be administered traditional trigeminal stimulation with dental TENS at tragus level. Tens will be turned on for 6 minutes in which the HRV parameters will be analyzed with the photoplethysmograph and compared with the data obtained in the TUD group.
干预措施: device that stimulates the tragus (Device)
TUD group
an intraoral device will be administered in the TUD group in order to provide the stimulation of the dorsal surface of the tongue with dental TENS. The trial will last approximately 24 minutes, after the first 6 minutes, TENS activation will take place and how HRV values change will be evaluated. The Heart rate Variability parameters will be analysed with photopletismographic wave after 6 minutes of tongue stimulation
干预措施: device that stimulates the dorsal surface of the tongue (Device)
结局指标
主要结局
Changes on Root mean square standard deviation (RMSSD) parameter
时间窗: 12 minutes
Whether or not HRV parameter (RMSSD) improve following tongue and tragus stimulation will be assessed by photopletismographic wave
Changes on Low Frequency parameter (LF)
时间窗: 12 minutes
Whether or not HRV parameter (LF) improve following tongue and tragus stimulation will be assessed by photopletismographic wave
次要结局
未报告次要终点
研究者
Sara Di Nicolantonio
PhD candidate
University of L'Aquila