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Completed

NCT Number: NCT06086236

Vagus Nerve Stimulation Effects on Autonomic Nervous System Activity

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.

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Key information

Conditions

Vagus Nerve Stimulation

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Igdir University

Iğdır, Merkez, 76000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous Auricular Vagus Nerve Stimulation

Device

Through a special Ear set, bilateral Transcutaneous Auricular Vagus Nerve Stimulation was applied to all participants for 20 minutes.

Primary outcomes

  1. Pulse Rate

    Time frame: Up to 6 Months

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

  2. Systolic Blood Pressure

    Time frame: Up to 6 Months

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

  3. Diastolic Blood Pressure

    Time frame: Up to 6 Months

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

Sponsors and collaborators

Lead sponsor

Bahçeşehir University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 17, 2023
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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