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Vagus Nerve Stimulation Effects on 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
NCT06086236
Enrollment
72
Registered
2023-10-17
Start date
2023-04-01
Completion date
2023-09-10
Last updated
2023-10-17

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

Conditions

Vagus Nerve Stimulation

Keywords

Vagus Nerve Stimulations, Diastolic Pressure, Pulse Rate, Systolic Pressure

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.

Interventions

DEVICETranscutaneous Auricular Vagus Nerve Stimulation

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

Sponsors

Bahçeşehir University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The evaluations were carried out by the second researcher

Intervention model description

After the participants were included in the study, heart rate variability was measured and divided into 4 groups according to PNS and SNS indexes.

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pulse RateUp to 6 MonthsThe pulse rate of the participants was measured with an electronic blood pressure monitor.
Systolic Blood PressureUp to 6 MonthsThe systolic blood pressure of the participants was measured with an electronic blood pressure monitor.
Diastolic Blood PressureUp to 6 MonthsThe diastolic blood pressure of the participants was measured with an electronic blood pressure monitor.

Countries

Turkey (Türkiye)

Outcome results

None listed

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