| 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
|
|
|
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
|
|
|
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. |