How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?
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
- Tolerability Measured by Tolerability Questionnaire
研究概览
简要总结
The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants will be blinded to which protocol they are receiving during data collection. The investigator responsible for processing HRV data will be blinded to group assignment, and investigators will be blinded to group assignment when conducting qualitative data analysis.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •between the ages of 18-80 years
- •English speaking (must be able to consent and complete the interviews in English)
排除标准
- •chronic pain (average intensity >2/10 on 0-10 scale, for longer than 3 months)
- •acute pain of intensity greater than 3/10
- •chronic inflammatory conditions that are poorly controlled (e.g., diabetes, autoimmune disease)
- •any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)
- •currently taking Buprenorphine or recently stopped taking (within 1 month)
- •presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews
- •implants in the head or neck, cochlear implants, or pacemaker
- •head or neck metastasis or recent ear trauma
- •history of epilepsy
- •history of autonomic nervous system dysfunction (e.g., postural orthostatic tachycardia syndrome).
研究组 & 干预措施
Biphasic followed by monophasic taVNS group
Participants in the group "Biphasic followed by monophasic taVNS" will be in this group for up to 6 hours.
干预措施: Biphasic transcutaneous auricular vagus nerve stimulation (Device)
Biphasic followed by monophasic taVNS group
Participants in the group "Biphasic followed by monophasic taVNS" will be in this group for up to 6 hours.
干预措施: Monophasic transcutaneous auricular vagus nerve stimulation (Device)
Monophasic followed by biphasic taVNS group
Participants in the group "monophasic followed by biphasic" will be in this group for up to 6 hours.
干预措施: Biphasic transcutaneous auricular vagus nerve stimulation (Device)
Monophasic followed by biphasic taVNS group
Participants in the group "monophasic followed by biphasic" will be in this group for up to 6 hours.
干预措施: Monophasic transcutaneous auricular vagus nerve stimulation (Device)
结局指标
主要结局
Tolerability Measured by Tolerability Questionnaire
时间窗: Up to 3 hours
Tolerability will be assessed with a questionnaire with scores ranging from 0 (no discomfort) to 10 (worst pain imaginable) for comfort.
Tolerability Measured by Self Report
时间窗: Up to 3 hours
Tolerability will be assessed by self-report using semi-structured interviews conducted at the end of each study visit. Participants will report whether they experienced mild pain during each transcutaneous auricular vagus nerve stimulation (taVNS) protocol. The outcome measure is the count of participants who reported mild pain, as collected during interviews conducted at the end of each visit.
次要结局
- Change in Heart Rate Variability (HRV)(Baseline and up to 3 hours)
研究者
Marlon Wong
Clinical Associate Professor
University of Miami