The Effect Of Transcutaneous Auricular Vagus Nerve Stimulation On Sports Performance And Physiological Parameters

NCT04768738 | Completed DMC

• 1 other identifier: VNS001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVE: The aim of this study is to investigate the effect of non-invasive auricular VNS (Vagus Nerve Stimulation) on sportive performance and physiological parameters in healthy individuals. MATERIAL AND METHOD: 46 healthy young individuals aged 19.2(±1.5) years participated in the study. The participants were randomly divided into 3 groups as Above Threshold Group (n:15; 10 females, 5 males), Under Threshold Group (n:15; 10 females, 5 males) and Control Group (no stimulation) (n:16; 11 females, 5 males) according to the sensation of electrical current on ears. The participants were evaluated 3 times; before the application, after the first and second bicycle exercises. Numerical pain scale (NPS), pulse rate, blood pressure, respiratory rate, and distance travelled during exercise for sportive performance were recorded in kilometers as the evaluation method. The stimulation was done during the first bicycle exercise with 5 minutes of duration. The Kruskal-wallis, mann-whitney u test were used for the quantitative independent data obtained. In the analysis of qualitative independent data, chi-squared test was used.

Conditions

Healthy; Activity, Motor

Keywords

Transcutaneous auricular Vagus Nerve Stimulation; Sportive Performance; Physiological Parameters

Outcome Measures

Primary Outcomes (1)

• Sportive performance

  Athletic performance during exercise in healthy individuals, cycling length in kilometers. Measured twice, during first and second exercises.

  Change from Baseline at Second Exercise

Secondary Outcomes (11)

• Pulse

  Change from Baseline at 5 minutes

• Pulse

  15 minutes

• Numerical pain scale (NPS),

  Change from Baseline at 15 minutes

• Respiratory Rate

  Change from Baseline at 5 minutes

• Respiratory Rate

  15 minutes

Study Arms (3)

Above Threshold Group

EXPERIMENTAL

In the above threshold group, biphasic current was applied as follows; frequency 10 Hz, in Modulation mode (Modulation mode is a combination of pulse rate and pulse width modulation. The pulse rate and width are automatically varied in a cycle pattern. The pulse width is reduced by 50% from its original setting in 0.5 second, then the pulse rate is reduced by 50% from its original setting in 0.5 second. Total cycle time is 1 second.), the pulse width was 300 μs. The current intensity was kept constant where the participant felt the current comfortably and applied for 5 minutes.

Device: Auricular Vagus Nerve Stimulation Level Of Above Threshold; Diagnostic Test: 5 Minutes Bicycle Exercise

Subthreshold Group

EXPERIMENTAL

In the subthreshold group, biphasic current was applied as follows; frequency 10 Hz, in Modulation mode (Modulation mode is a combination of pulse rate and pulse width modulation. The pulse rate and width are automatically varied in a cycle pattern. The pulse width is reduced by 50% from its original setting in 0.5 second, then the pulse rate is reduced by 50% from its original setting in 0.5 second. Total cycle time is 1 second.), the pulse width was 300 μs. The parameters were the same with Above Threshold Group but the current was reduced to where the participant did not feel the current after the threshold value was reached and again applied for 5 minutes.

Device: Auricular Vagus Nerve Stimulation Level Of Subthreshold; Diagnostic Test: 5 Minutes Bicycle Exercise

Control Group

SHAM COMPARATOR

In the control group, bicycle exercise was performed under the same load with the current-free headset produced for sham applications for 5 minutes. Participants were shown that the device was working, but no current was given.

Device: Auricular Vagus Nerve Stimulation Sham Method; Diagnostic Test: 5 Minutes Bicycle Exercise

Interventions

Auricular Vagus Nerve Stimulation Level Of Above Threshold DEVICE

Biphasic current was applied as follows; frequency 10 Hz, in Modulation mode (Modulation mode is a combination of pulse rate and pulse width modulation. The pulse rate and width are automatically varied in a cycle pattern. The pulse width is reduced by 50% from its original setting in 0.5 second, then the pulse rate is reduced by 50% from its original setting in 0.5 second. Total cycle time is 1 second.), the pulse width was 300 μs. The current intensity was kept constant where the participant felt the current comfortably and applied for 5 minutes.

Above Threshold Group

Auricular Vagus Nerve Stimulation Level Of Subthreshold DEVICE

biphasic current was applied as follows; frequency 10 Hz, in Modulation mode (Modulation mode is a combination of pulse rate and pulse width modulation. The pulse rate and width are automatically varied in a cycle pattern. The pulse width is reduced by 50% from its original setting in 0.5 second, then the pulse rate is reduced by 50% from its original setting in 0.5 second. Total cycle time is 1 second.), the pulse width was 300 μs. The parameters were the same with Above Threshold Group but the current was reduced to where the participant did not feel the current after the threshold value was reached and again applied for 5 minutes.

Also known as: Level Of Subthreshold

Subthreshold Group

Auricular Vagus Nerve Stimulation Sham Method DEVICE

Participants were shown that the device was working, but no current was given.

Also known as: Sham Method

Control Group

5 Minutes Bicycle Exercise DIAGNOSTIC_TEST

Participants in this group were asked to perform bicycle exercise with maximum performance under 50 watts for 5 minutes.

Also known as: Bicycle Exercise

Above Threshold Group; Control Group; Subthreshold Group

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years age
• Being healthy

You may not qualify if:

• any known disease
• any drug usage

Sponsors & Collaborators

• Sinop University: lead

Study Sites (1)

Sefa Haktan Hatık

Sinop, Turkeli, 57900, Turkey (Türkiye)

Location

Related Publications (28)

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MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSc, PhD(c)

Model Details: 46 healthy young individuals aged 19.2±1.5 years participated in the study. The participants were randomly divided into 3 groups as Above Threshold Group (n:15; 10 females, 5 males), Under Threshold Group (n:15; 10 females, 5 males) and Control Group (no stimulation) (n:16; 11 females, 5 males) according to the sensation of electrical current on ears. The participants were evaluated 3 times; before the application, after the first and second bicycle exercises. Numerical pain scale (NPS), pulse rate, blood pressure, respiratory rate, and distance travelled during exercise for sportive performance were recorded in kilometers as the evaluation method. The stimulation was done during the first bicycle exercise with 5 minutes of duration. The Kruskal-wallis, mann-whitney u test were used for the quantitative independent data obtained. In the analysis of qualitative independent data, chi-squared test was used.

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 24, 2021
• Study Start: February 1, 2020
• Primary Completion: February 1, 2020
• Study Completion: November 1, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)