Effect of Recording Duration on Heart Rate Variability During Transcutaneous Auricular Vagus Nerve Stimulation: A Randomized, Sham-Controlled Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Difference in 5-minute lnRMSSD During Active taVNS Compared With Sham Stimulation
研究概览
简要总结
This study aims to evaluate how different heart rate variability (HRV) recording durations reflect autonomic nervous system responses during transcutaneous auricular vagus nerve stimulation (taVNS) in healthy adults. In a randomized, sham-controlled crossover design, participants will attend two separate sessions and receive both active taVNS and sham stimulation in randomized order. During each session, a continuous 10-minute HRV recording will be obtained, and 1-minute, 5-minute, and 10-minute analysis windows will be compared. Blood pressure and pulse will also be measured before and after stimulation. The study will investigate whether shorter or longer HRV recording durations provide results comparable to the standard 5-minute recording and which duration most reliably detects autonomic changes during taVNS.
详细描述
The vagus nerve plays a central role in autonomic regulation, and heart rate variability (HRV) is a widely used noninvasive marker of autonomic nervous system activity. Transcutaneous auricular vagus nerve stimulation (taVNS) has increasingly been used in experimental and clinical research as a noninvasive method to modulate vagal activity. Although previous studies suggest that taVNS may influence parasympathetic activity, HRV measurement duration remains an important methodological issue. Standard short-term HRV analysis is commonly based on 5-minute recordings, but ultra-short and longer recordings are also used, and their validity during taVNS has not been sufficiently clarified.
This study is designed to determine whether different HRV recording durations provide comparable and reliable information during taVNS. The study will use a randomized, sham-controlled crossover design. Healthy adult participants will attend two sessions separated by a washout period of 48 to 72 hours. In one session, participants will receive active taVNS; in the other, they will receive sham stimulation. The order of sessions will be randomized.
During each session, HRV data will be collected continuously for 10 minutes using a Polar H10 chest strap. From this single uninterrupted recording, 1-minute, 5-minute, and 10-minute analysis windows will be derived. HRV parameters from time-domain and frequency-domain analyses will be calculated. Blood pressure and pulse will be measured before and after the intervention using an automated upper-arm blood pressure monitor.
Active taVNS will be applied to the cymba conchae region of the ear using commonly reported stimulation parameters. Sham stimulation will be delivered with the same device and similar sensory conditions, but at a non-vagal ear location to minimize physiologic vagal effects. This design is intended to control for nonspecific sensory and expectation-related effects.
The primary objective is to assess whether the standard 5-minute HRV recording during taVNS detects autonomic effects compared with sham stimulation. Secondary objectives are to examine the agreement between 1-minute, 5-minute, and 10-minute HRV measurements and to evaluate whether shorter or longer recordings provide additional methodological value. The relationship between HRV findings and hemodynamic responses, including blood pressure and pulse, will also be explored. This study may help identify the most appropriate HRV recording duration for future taVNS research and contribute to methodological standardization in this field.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The study will use partial blinding. The investigator performing physiologic measurements and the researcher responsible for statistical analysis will be blinded to intervention assignment. Data will be analyzed using coded datasets, and group identities will be revealed only after completion of the analyses. The researcher delivering the intervention cannot be blinded because active taVNS and sham stimulation require different application sites.
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 volunteers aged 18 to 40 years
- •Able and willing to provide informed consent
- •Able to tolerate active transcutaneous auricular vagus nerve stimulation and sham stimulation
- •Able to comply with study instructions, including restrictions related to caffeine, nicotine, and heavy exercise before assessment
- •No condition preventing heart rate variability, blood pressure, or pulse measurements
排除标准
- •Diagnosed cardiovascular disease, arrhythmia, or pacemaker use
- •History of neurologic disease that may affect autonomic nervous system function
- •Regular use of medications that may affect heart rate variability or autonomic responses, including beta blockers, antiarrhythmics, or anticholinergic drugs
- •Active ear infection, dermatologic lesion, or any ear condition that may interfere with stimulation
- •Marked pain, discomfort, or intolerance during stimulation
- •Acute infection, fever, or other acute health problem on the measurement day
- •Heart rate variability data that cannot be evaluated because of excessive motion artifact
研究组 & 干预措施
taVNS First
Participants assigned to this sequence will receive active transcutaneous auricular vagus nerve stimulation (taVNS) during the first session and sham stimulation during the second session, with a 48- to 72-hour washout period between sessions.
干预措施: Transcutaneous Auricular Vagus Nerve Stimulation (Device)
Sham First
Participants assigned to this arm will receive sham stimulation during the first session and active transcutaneous auricular vagus nerve stimulation (taVNS) during the second session, with a 48- to 72-hour washout period between sessions.
干预措施: Sham Stimulation (Device)
结局指标
主要结局
Difference in 5-minute lnRMSSD During Active taVNS Compared With Sham Stimulation
时间窗: During the 10-minute intervention period at each study session
The primary outcome is the between-condition difference in 5-minute heart rate variability, assessed by lnRMSSD derived from the continuous RR interval recording obtained during the 10-minute intervention period. The 5-minute analysis window is the prespecified standard short-term HRV measure used to compare active transcutaneous auricular vagus nerve stimulation with sham stimulation.
次要结局
- Agreement Between 1-minute and 5-minute HRV Measurements During Active taVNS(During the 10-minute intervention period at each active taVNS session)
- Comparison of 10-minute and 5-minute HRV Measurements During Active taVNS(During the 10-minute intervention period at each active taVNS session)
- Effect of Recording Duration on HRV Differences Between Active taVNS and Sham Stimulation(During the 10-minute intervention period at each study session)
- Change in Systolic and Diastolic Blood Pressure After Active taVNS Compared With Sham Stimulation(Immediately before and immediately after each 10-minute intervention session)
- Change in Pulse Rate After Active taVNS Compared With Sham Stimulation(Immediately before and immediately after each 10-minute intervention session)
研究者
SEFA HAKTAN HATIK
Assistant professor
Sinop University
