Investigation of the Acute Effects of Different Frequency Applications of Transcutaneous Auricular Vagus Nerve Stimulation on Autonomic Physiological Responses in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in RMSSD
研究概览
简要总结
This randomized, participant-blinded, sham-controlled crossover study aims to investigate the acute effects of different frequency applications of transcutaneous auricular vagus nerve stimulation (taVNS) on autonomic physiological responses in healthy adults. Participants will receive sham (0 Hz), 10 Hz, 25 Hz, 50 Hz, and 100 Hz taVNS in separate sessions with washout periods between visits. Heart rate variability, blood pressure, pulse rate, respiratory rate, and subjective discomfort will be assessed before and after each intervention session.
详细描述
The vagus nerve is a major regulator of the parasympathetic branch of the autonomic nervous system. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique applied to auricular regions innervated by the auricular branch of the vagus nerve. Although taVNS has been reported to modulate autonomic function, the acute physiological effects of different stimulation frequencies remain insufficiently characterized.
This study is designed as a randomized, participant-blinded, sham-controlled crossover trial in healthy adults aged 18 to 40 years. Each participant will undergo five intervention conditions in randomized order: sham (0 Hz), 10 Hz, 25 Hz, 50 Hz, and 100 Hz taVNS. Sessions will be separated by 48 to 72 hours to minimize carryover effects. Each stimulation session will last 10 minutes.
Primary autonomic outcomes will be derived from heart rate variability parameters obtained using a Polar H10 chest strap and analyzed with Kubios HRV software. Secondary physiological outcomes will include systolic and diastolic blood pressure, pulse rate, respiratory rate, and subjective discomfort measured using a visual analog scale. The study aims to identify frequency-specific autonomic response profiles and to evaluate whether respiratory rate influences heart rate variability changes associated with taVNS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to whether the intervention session involves active taVNS or sham stimulation. The care provider/investigator cannot be blinded because of the technical requirements of device application and condition setup.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18 to 40 years
- •No known neurological, cardiovascular, respiratory, or metabolic disease
- •Able to understand study procedures and provide written informed consent
- •No active infection, open wound, or dermatological lesion in the ear region that would interfere with taVNS application
- •Willing and able to attend all study visits
排除标准
- •History of cardiac arrhythmia, pacemaker, or any implanted electronic medical device History of hypertension, diabetes, chronic pulmonary disease, epilepsy, or systemic disease affecting autonomic nervous system function
- •Regular use of medications that may affect autonomic function (e.g., beta-blockers, antidepressants, antiarrhythmics)
- •Intense physical exercise within the previous 24 hours
- •High caffeine or alcohol intake within 12 hours prior to assessment
- •Active smoking on the assessment day
- •Pregnancy or suspected pregnancy
- •Severe discomfort during stimulation (VAS >= 7), dizziness, nausea, or unwillingness to continue
- •Any condition judged by the investigators to make participation unsuitable'
研究组 & 干预措施
taVNS 50 Hz
Participants receive active transcutaneous auricular vagus nerve stimulation at 50 Hz during one study session.
干预措施: taVNS 50 Hz (Device)
taVNS 100 Hz
Participants receive active transcutaneous auricular vagus nerve stimulation at 100 Hz during one study session.
干预措施: taVNS 100 Hz (Device)
taVNS 10 Hz
Participants receive active transcutaneous auricular vagus nerve stimulation at 10 Hz during one study session.
干预措施: taVNS 10 Hz (Device)
taVNS 25 Hz
Participants receive active transcutaneous auricular vagus nerve stimulation at 25 Hz during one study session.
干预措施: taVNS 25 Hz (Device)
Sham taVNS
Participants receive sham stimulation during one study session.
干预措施: Sham taVNS (Device)
结局指标
主要结局
Change in RMSSD
时间窗: Immediately before and immediately after each 10-minute intervention session
Change in the root mean square of successive differences (RMSSD) from pre-intervention to post-intervention under each stimulation condition.
Change in High-Frequency Heart Rate Variability (HF-HRV)
时间窗: Immediately before and immediately after each 10-minute intervention session
Change in high-frequency heart rate variability (HF-HRV) from pre-intervention to post-intervention under each stimulation condition.
Change in Root Mean Square of Successive Differences (RMSSD)
时间窗: Immediately before and immediately after each 10-minute intervention session
Change in the root mean square of successive differences (RMSSD) from pre-intervention to post-intervention under each stimulation condition.
次要结局
- Change in diastolic blood pressure(Immediately before and immediately after each intervention session)
- Change in pulse rate(Immediately before and immediately after each intervention session)
- Change in respiratory rate(Immediately before and immediately after each intervention session)
- Change in subjective discomfort assessed by VAS(Immediately before and immediately after each intervention session)
- Change in SDNN(Immediately before and immediately after each intervention session)
- Change in LF power(Immediately before and immediately after each intervention session)
- Change in LF/HF ratio(Immediately before and immediately after each intervention session)
- Change in systolic blood pressure(Immediately before and immediately after each intervention session)
- Change in Standard Deviation of Normal-to-Normal RR Intervals (SDNN)(Immediately before and immediately after each 10-minute intervention session)
- Change in Low-Frequency (LF) Power(Immediately before and immediately after each 10-minute intervention session)
- Change in LF/HF Ratio(Immediately before and immediately after each 10-minute intervention session)
- Change in Systolic Blood Pressure(Immediately before and immediately after each 10-minute intervention session)
- Change in Diastolic Blood Pressure(Immediately before and immediately after each 10-minute intervention session)
- Change in Pulse Rate(Immediately before and immediately after each 10-minute intervention session)
- Change in Respiratory Rate(Immediately before and immediately after each 10-minute intervention session)
- Change in Subjective Discomfort Assessed by Visual Analog Scale (VAS)(Immediately before and immediately after each 10-minute intervention session)
研究者
SEFA HAKTAN HATIK
Assistant Professor
Sinop University