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临床试验/NCT06312293
NCT06312293已完成不适用

Transcutaneous Auricular Vagus Nerve Stimulation: Comparison of Effectiveness of In-ear and Behınd-ear Stimulation

Bahçeşehir University2 个研究点 分布在 2 个国家目标入组 76 人开始时间: 2023年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
试验地点
2
主要终点
Heart Rate Variability

研究概览

简要总结

The use of vagus nerve stimulation (VSS), one of the examples of neuromodulation therapies, continues to increase in the medical field. Basically, invasive (iVSS) and transcutaneous VSS (tVSS) can be performed. tVSS is more preferred because of its advantages such as easy application, not requiring surgical procedure and having fewer side effects. VSS has long been an approved treatment modality in the treatment of epilepsy and refractory depression. tVSS can be administered from the auricular-auricular or posterior ear region. The vagus nerve (VS) belongs to the parasympathetic branch of the autonomic nervous system and has an effect on vital functions. There are also studies in the literature showing that VS stimulation reduces inflammation. In addition to this effect, the vagus nerve may also show analgesic activity through pain-related pathways. Due to its anti-inflammatory and analgesic effects, VSS has become a new treatment method in diseases in which various inflammatory processes are shown in the etiology such as inflammatory bowel diseases, musculoskeletal system diseases and central nervous system diseases.

详细描述

There are no generally accepted values for taVNS (transcutaneous auricular vagus nerve stimulation) application parameters (amplitude, frequency, intensity, duration, side); therefore, there are heterogeneous applications in studies. In a meta-analysis on the safety profile of taVSS, local skin irritation (18. 2%), headache (3.6%), nasopharyngitis (1.7%), dizziness (1.4%) and nausea (1.1%) were reported and taVSS treatment was reported as an effective and safe treatment with these side effects, most of which were transient and did not require additional intervention.

During taVNS, autonomic activities increase in favour of the parasympathetic system and this results in an increase in heart rate variability (HRV). Although an increase in HRV has been demonstrated by different studies, the factors that can predict the change in HRV are not clear. In a study by Geng et al. using taVSS, it was observed that HRV indicators representing vagal nerve activity increased significantly when stimulation was performed in the morning, but evening stimulation did not yield similar results. In addition, they found that improvements in measures of autonomic balance were more pronounced in the presence of lower vagal activity; they also found that by increasing the duration of stimulation, the effect of taVNS on HRV was not regulated by duration. In other words, HRV changes had the best effect only at the beginning of stimulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • To be 18 years of age or older,
  • Not having any acute or chronic health problems,
  • No previous transcutaneous vagus nerve stimulation application.

排除标准

  • Using drugs, alcohol or smoking
  • Being in the post menopausal phase
  • Pregnancy history
  • Known history of acute or chronic illness
  • Having received any medication affecting the autonomic nervous system

研究组 & 干预措施

In-Ear stimulation

Experimental

Participants in this group underwent intra-ear transcutaneous vagus nerve simulation.

干预措施: Transcutaneous Vagus Nerve Stimulation (Device)

Behind the ear stimulation

Experimental

Participants in this group underwent transcutaneous vagus nerve simulation behind the ear.

干预措施: Transcutaneous Vagus Nerve Stimulation (Device)

In-Ear stimulation (device switched off)

Placebo Comparator

In order to see the placebo effect of in-ear simulation in participants in this group, the electrode was placed inside the ear with the device closed and the results were evaluated.

干预措施: Transcutaneous Vagus Nerve Stimulation (Device)

Behind the ear stimulation (device switched off)

Placebo Comparator

In order to see the placebo effect of behind-ear simulation in participants in this group, the electrode was placed inside the ear with the device closed and the results were evaluated.

干预措施: Transcutaneous Vagus Nerve Stimulation (Device)

结局指标

主要结局

Heart Rate Variability

时间窗: Baseline and immediately after the intervention

The effectiveness of vagus nerve stimulation, its effect on autonomic nervous system activity was evaluated using heart rate variability. Polar H7 device was used for this. The heart rate was recorded non-invasively over the chest for 5 minutes and the beat-to-beat (R-R) variability was measured with Kubios software.

次要结局

未报告次要终点

研究者

发起方
Bahçeşehir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alper Percin

Principal Investigator

Bahçeşehir University

研究点 (2)

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