Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04768738
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2021-02-03
Brief Title:
The Effect Of Transcutaneous Auricular Vagus Nerve Stimulation On Sports Performance And Physiological Parameters
Sponsor:
Sinop University
Organization:
Sinop University
Study Overview
Official Title:
The Effect Of Transcutaneous Auricular Vagus Nerve Stimulation On Sports Performance And Physiological Parameters In Healthy Young Individuals Randomized Double-Blind Study
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VNS001
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 19215 years participated in the study The participants were randomly divided into 3 groups as Above Threshold Group n15 10 females 5 males Under Threshold Group n15 10 females 5 males and Control Group no stimulation n16 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
MATERIAL AND METHOD 46 healthy young individuals aged 19215 years participated in the study The participants were randomly divided into 3 groups as Above Threshold Group n15 10 females 5 males Under Threshold Group n15 10 females 5 males and Control Group no stimulation n16 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
Detailed Description:
This study included 46 individuals aged 18-35 years in the home patient care laboratory at Sinop University Vocational School of Turkeli Priorities were explained and the permission of the individuals was obtained The number of females and males was divided into 3 groups as randomized Participants were evaluated by Numerical pain scale NPS pulse rate blood pressure respiratory rate and saturation measurement In addition the distance travelled during the exercise for sportive performance was recorded in kilometers In the study evaluation was conducted 3 times before the application after the first and second bicycle exercises
The study was double-blind randomized Participants in the whole group were asked to perform bicycle exercise with maximum performance under 50 watts for 5 minutes In all groups Vagustim device was used for stimulation 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 05 second then the pulse rate is reduced by 50 from its original setting in 05 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 VNS was applied bilaterally to transmit current from the tragus and concha parts of the ear After the first bicycle exercise the participants were re-evaluated In the second bicycle exercise it was asked to perform for 5 minutes under the same load without any application The study was evaluated for the third time and the study was completed
In the subthreshold group the parameters were the same 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 It was re-evaluated after the first bicycle exercise In the second bicycle exercise he was asked to perform bicycle exercise with maximum performance for 5 minutes under the same load without any application The study was evaluated for the third time and the study was completed
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 It was re-evaluated after the first bicycle exercise In the second bicycle exercise the device was removed and asked to perform bicycle exercise with maximum performance for 5 minutes under the same load The study was evaluated for the third time and the study was completed
The study was double-blind randomized Participants in the whole group were asked to perform bicycle exercise with maximum performance under 50 watts for 5 minutes In all groups Vagustim device was used for stimulation 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 05 second then the pulse rate is reduced by 50 from its original setting in 05 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 VNS was applied bilaterally to transmit current from the tragus and concha parts of the ear After the first bicycle exercise the participants were re-evaluated In the second bicycle exercise it was asked to perform for 5 minutes under the same load without any application The study was evaluated for the third time and the study was completed
In the subthreshold group the parameters were the same 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 It was re-evaluated after the first bicycle exercise In the second bicycle exercise he was asked to perform bicycle exercise with maximum performance for 5 minutes under the same load without any application The study was evaluated for the third time and the study was completed
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 It was re-evaluated after the first bicycle exercise In the second bicycle exercise the device was removed and asked to perform bicycle exercise with maximum performance for 5 minutes under the same load The study was evaluated for the third time and the study was completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None