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Vagus Nerve Stimulation for Autonomic Nervous System Activity

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05906940
Enrollment
72
Registered
2023-06-18
Start date
2023-07-01
Completion date
2023-12-30
Last updated
2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Nervous System Imbalance

Keywords

Autonomic Nervous Systems, Vagal Nerve Stimulation, Heart Rates

Brief summary

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.

Detailed description

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.

Interventions

DEVICETranscutaneous Vagus Nerve Stimulation

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.

Sponsors

Bahçeşehir University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Heart Rate Variability Parameters-Stress Index5 minutes (short measurement) measurement of heart rate variabilityStress index which is a geometric measure of HRV reflecting cardiovascular system stress. High values of SI indicate reduced variability and high sympathetic cardiac activation.
Heart Rate Variability Parameters-RMSSD5 minutes (short measurement) measurement of heart rate variabilityRMSSD is a measure of short-term (beat-by-beat) variability. It equals the root mean square of successive differences.
Heart Rate Variability Parameters-LF (Low Frequency)5 minutes (short measurement) measurement of heart rate variabilityPower in the Low Frequency band of the HRV spectrum, often between 0.04 - 0.15 Hz, often reported in units of milliseconds-squared.
Heart Rate Variability Parameters-HF (High Frequency)5 minutes (short measurement) measurement of heart rate variabilityPower in the High Frequency band of the HRV spectrum, often between 0.15-0.40 Hz, often reported in units of milliseconds-squared.
Heart Rate Variability Parameters-LF/HF Ratio5 minutes (short measurement) measurement of heart rate variabilityLF/HF Ratio: A ratio of Low Frequency to High Frequency.
Heart Rate Variability Parameters-SNS Index5 minutes (short measurement) measurement of heart rate variabilitySympathetic 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
Heart Rate Variability Parameters-PNS Index5 minutes (short measurement) measurement of heart rate variabilityParasympathetic 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)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026