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CTRI Number  CTRI/2024/09/073377 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 03/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Crossover Trial 
Public Title of Study   To study the effects of trans auricular vagal nerve stimulation on the autonomic nervous system. 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gaurav Sharma 
Designation  Assistant Professor 
Affiliation  AIIMS Rajkot 
Address  All India Institute of Medical Sciences, Rajkot
Department of Physiology, 1st Floor Academic building, AIIMS Rajkot
Rajkot
GUJARAT
360006
India 
Phone  7417574751  
Fax    
Email  drgauravsharma.jnmc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gaurav Sharma 
Designation  Assistant Professor 
Affiliation  AIIMS Rajkot 
Address  All India Institute of Medical Sciences, Rajkot
Department of Physiology, First Floor Academic Building, AIIMS Rajkot

GUJARAT
360006
India 
Phone  7417574751  
Fax    
Email  drgauravsharma.jnmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gaurav Sharma 
Designation  Assistant Professor 
Affiliation  AIIMS Rajkot 
Address  All India Institute of Medical Sciences, Rajkot
Department of Physiology, First Floor, Academic Building, AIIMS Rajkot.

GUJARAT
360006
India 
Phone  7417574751  
Fax    
Email  drgauravsharma.jnmc@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of medical Sciences,Para pipaliya, Rajkot, Gujarat, India 360006 
 
Primary Sponsor  
Name  AIIMS Rajkot 
Address  All India Institute of Medical Sciences, Rajkot, Gujarat, India 360006 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gaurav Sharma  AIIMS Rajkot  Autonomic Function Testing Lab, Department of Physiology, First Floor, Academic Building, All India Institute of Medical Sciences, Rajkot, Para Pipaliya, Rajkot, Gujarat 360006
Rajkot
GUJARAT 
7417574751

drgauravsharma.jnmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Apparently Healthy Individual 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Active taVNS applied on the ear  taVNS will be applied on the ear and its effect on the sympathetic and parasympathetic parameters will be studied and analysed. 
Comparator Agent  sham taVNS applied on the ear  Sham taVNS will be applied on the ear and its effect on the sympathetic and parasympathetic parameters will be studied and analysed. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Apparently Healthy Individuals free from any neurological, cardiac, or psychiatric illness. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the effect of transauricular vagal nerve stimulation (taVNS) on heart rate variability.  Immediate effects will be studied. The total study duration per subject is less than 01 hour. 
 
Secondary Outcome  
Outcome  TimePoints 
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. 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   16/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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