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Completed

NCT Number: NCT05906940

Vagus Nerve Stimulation for Autonomic Nervous System Activity

There are no generally accepted values for transcutaneous vagus nerve stimulation (taVSS application parameters (amplitude, frequency, intensity, duration, side) yet, therefore there are heterogeneous applications in studies. Although positive effects have been shown in different neurological, psychiatric and musculoskeletal diseases, taVSS treatment is not available yet. It is not clear which parameters are important in patient selection.In this study, it was aimed to investigate the change of taVSS effect in healthy individuals according to the level of autonomic nervous system activity before stimulation.

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Key information

Conditions

Autonomic Nervous System Imbalance

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iğdır University

Iğdır, Iğdır Central, 76000, Turkey (Türkiye)

About this study

Healthy individuals between the ages of 18-45 without any disease will be included in the study. Male and female participants will be included in the study. Heart rate variability will be measured after participants are included in the study. A short 5-minute measurement will be made with the Polar H7 device, which can be measured with the belt attached to the chest. Heart Rate Variability measurement will be analyzed with the Kubios HRV program. Participants will be distributed to groups according to the SNS index and PNS index values obtained as a result of the Kubios analysis. According to the index scores obtained, the distribution of the groups will be made as <-2, between -2 and +2 and >2. Afterwards, 20 minutes of taVSS stimulation will be performed. As a vagus stimulation protocol, bilateral auricular stimulation and stimulation frequency of 10 Hz (Heartz), pulse width of 300 µs (microseconds) for 20 minutes, biphasic application will be given to each participant 2 times, with at least 48 hours between them.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy participants between the ages of 18-45 will be included in the study.

Exclusion criteria

  • Having an acute or chronic disease,
  • Having previously undergone transcutaneous vagus nerve stimulation,
  • Not smoking or using alcohol,
  • Being in the post-menopausal stage in women,
  • Being in the post-andropausal period in men,
  • Being on constant medication,
  • In menstruating women, stimulation and heart rate assessment will be postponed to the next week.

Treatment and study plan

Transcutaneous vagus nerve stimulation

Device

As a vagus stimulation protocol, bilateral auricular stimulation and stimulation frequency of 10 Hz, pulse width of 300 µs, biphasic application for 20 minutes, each participant will be stimulated twice, with at least 48 hours between them.

Primary outcomes

  1. Heart Rate Variability Parameters-Stress Index

    Time frame: 5 minutes (short measurement) measurement of heart rate variability

    Stress index which is a geometric measure of HRV reflecting cardiovascular system stress. High values of SI indicate reduced variability and high sympathetic cardiac activation.

  2. Heart Rate Variability Parameters-RMSSD

    Time frame: 5 minutes (short measurement) measurement of heart rate variability

    RMSSD is a measure of short-term (beat-by-beat) variability. It equals the root mean square of successive differences.

  3. Heart Rate Variability Parameters-LF (Low Frequency)

    Time frame: 5 minutes (short measurement) measurement of heart rate variability

    Power in the Low Frequency band of the HRV spectrum, often between 0.04 - 0.15 Hz, often reported in units of milliseconds-squared.

  4. Heart Rate Variability Parameters-HF (High Frequency)

    Time frame: 5 minutes (short measurement) measurement of heart rate variability

    Power in the High Frequency band of the HRV spectrum, often between 0.15-0.40 Hz, often reported in units of milliseconds-squared.

  5. Heart Rate Variability Parameters-LF/HF Ratio

    Time frame: 5 minutes (short measurement) measurement of heart rate variability

    LF/HF Ratio: A ratio of Low Frequency to High Frequency.

  6. Heart Rate Variability Parameters-SNS Index

    Time frame: 5 minutes (short measurement) measurement of heart rate variability

    Sympathetic cardiac activity is known to 1) increase heart rate, 2) decrease HRV, reducing especially quick RSA related changes in RR interval, and 3) increase the ratio between lower frequency and higher frequency oscillations in HRV data

  7. Heart Rate Variability Parameters-PNS Index

    Time frame: 5 minutes (short measurement) measurement of heart rate variability

    Parasympathetic cardiac activity is known to 1) decrease heart rate (i.e. increase the time interval between successive heart beats), 2) increase HRV via enhanced respiratory sinus arrhythmia (RSA) component (i.e. increasing the quick changes in RR interval linked to respiration - shortening of RR intervals during inhalation and lengthening of RR intervals during exhalation), and 3) decrease the ratio between lower frequency and higher frequency oscillations in HRV time series (i.e. increase the relative amount of quick RSA originated fluctuations in HRV compared to slower short-term fluctuations)

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
Jun 18, 2023
Registry last updated
Jan 5, 2024

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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