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Clinical Trials/NCT06086236
NCT06086236
Completed
Not Applicable

Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Basic Autonomic Nervous System Activity

Bahçeşehir University1 site in 1 country72 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vagus Nerve Stimulation
Sponsor
Bahçeşehir University
Enrollment
72
Locations
1
Primary Endpoint
Systolic Blood Pressure
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Transcutaneous Auricular Vagus nerve stimulation may be successful in cardiac modulation because of the cardiac connections of the vagal nerve. Therefore, in order to observe the cardiac effects, it was analysed the changes in pulse rate, systolic and diastolic blood pressure after transcutaneous auricular vagus nerve stimulation application.

Detailed Description

Participants were divided into four groups (Figure 1) according to PNS and SNS indexes as Group 1 (PNS index \<-2, SNS index \>+2), Group 2 (PNS index \<-2, SNS index \<+2), Group 3 (PNS index \>-2, SNS index \>+2), Group 4 (PNS index \>-2, SNS index \<+2). Participants were assessed with blood pressure, pulse rate and HRV before and after taVNS stimulation. Sympathetic nervous system (SNS) index and parasympathetic nervous system (PNS) index values were assumed to be between -2 and +2 (95%) in the normal population according to Kubios software, and the grouping method was based on this situation.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
September 10, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bahçeşehir University
Responsible Party
Principal Investigator
Principal Investigator

Alper Percin

Principal Investigator

Bahçeşehir University

Eligibility Criteria

Inclusion Criteria

  • Age between 18 and 40 years old.
  • No previous vagus nerve stimulation

Exclusion Criteria

  • Using of any drug, alcohol or smoking.
  • Pregnancy.
  • Known history of acute or chronic illness.
  • Being in the post or peri-menopausal stage.

Outcomes

Primary Outcomes

Systolic Blood Pressure

Time Frame: Up to 6 Months

The systolic blood pressure of the participants was measured with an electronic blood pressure monitor.

Diastolic Blood Pressure

Time Frame: Up to 6 Months

The diastolic blood pressure of the participants was measured with an electronic blood pressure monitor.

Pulse Rate

Time Frame: Up to 6 Months

The pulse rate of the participants was measured with an electronic blood pressure monitor.

Study Sites (1)

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