Vagus Nerve Stimulation for Autonomic Nervous System Activity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-12-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Autonomic Nervous System Imbalance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Health Participants

Participants in this group will be measured heart rate variability before and after transcutaneous vagus nerve stimulation.

Group Type EXPERIMENTAL

Transcutaneous Vagus Nerve Stimulation

Intervention Type 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.

Interventions

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Transcutaneous 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes