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临床试验/CTRI/2024/09/073377
CTRI/2024/09/073377尚未招募1/2 期

Virtual Workout Approach to Reaping the Benefits of Physical Activity: Exploring the Effects of Transauricular Vagal Nerve Stimulation (taVNS) on Sympatho-vagal activity in Healthy Individuals

AIIMS Rajkot1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年9月16日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
To study the effect of transauricular vagal nerve stimulation (taVNS) on heart rate variability.

研究概览

简要总结

In this research project we will use a specific study design called a prospective cross-sectional study. They plan to study the effects of a treatment called transcutaneous auricular vagus nerve stimulation (taVNS) on heart rate variability (HRV) recorded by ECG and Respiratory rate (Deep Breathing test) on 32 participants.

To participate in the study, individuals must meet strict eligibility criteria, like not having certain medical conditions or taking certain medications. They also have to follow specific rules before the testing session, such as not smoking or exercising for a certain amount of time.

Once participants agree to take part, the researchers will measure their height and weight and ask them questions about their physical activity level. Then, participants will sit comfortably and relax for 10 minutes before the researchers start recording their heart activity. The study involves two types of sessions for each participant: a real taVNS session and a fake taVNS session (sham). The active or and sham stimulation will be given to either right or left ear assigned randomly. These sessions will be randomly assigned to participants to avoid any bias. During these sessions, electrical stimulation will be applied to specific parts of the ear using a special technique. The researchers will adjust the stimulation intensity based on the participant’s perception of sensation. The research team will carefully record and analyze the data from these sessions to see if taVNS has any effects on HRV. This study is designed to provide reliable and unbiased results about the treatment’s effectiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Apparently Healthy Individuals free from any neurological, cardiac, or psychiatric illness.

排除标准

  • Current cardiac or neurological diseases (Epilepsy or migraine), and family history of seizure disorders, taking psychiatric medications at the time of enrollment.
  • abstain from smoking for at least 5 hours prior to the testing session, avoid alcohol consumption and exercise for a minimum of 24 hours before testing, and refrain from consuming caffeinated drinks and meals for at least 2 hours preceding the testing session.

结局指标

主要结局

To study the effect of transauricular vagal nerve stimulation (taVNS) on heart rate variability.

时间窗: Immediate effects will be studied. The total study duration per subject is less than 01 hour.

次要结局

  • to study the effect of right & left vagal nerve stimulation on HRV(Immediately after the exposure of 5 minutes. The total duration of study per patient is less than 01 hour.)

研究者

发起方
AIIMS Rajkot
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Gaurav Sharma

AIIMS Rajkot

研究点 (1)

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