NCT06740032

Brief Summary

The goal of this clinical trial is to investigate whether vagus stimulation and breathing exercises are more effective in healthy adults. Are vagal stimulation and breathing exercises effective on autonomic functions and the somatic system in healthy adults? Participants' results for autonomic functions and somatic system will be compared for both groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

November 29, 2024

Last Update Submit

December 13, 2024

Conditions

Vagus Nerve Stimulations

Keywords

Auricular vagus nerve stimulationdeep breathing exercises

Outcome Measures

Primary Outcomes (4)

  • HRV results

    Measuring autonomic values for 5 minutes

    5 minutes

  • Muscle Natural Oscillation Frequency

    Biomechanical measurements of specific muscles

    5 minutes

  • Muscle Dynamic Stiffness [N/m]

    measured using the myoton device

    5 minutes

  • Mechanical Stress Relaxation Time [ms]

    measured using the myoton device

    5 minutes

Secondary Outcomes (3)

  • Perceived stress scale

    5 minutes

  • Pulse rate

    5 minutes

  • blood pressure

    5 minutes

Study Arms (2)

autonomic function

ACTIVE COMPARATOR
Other: Transcutaneous vagus nerve stimulationOther: Deep breath exercise

somatic function

ACTIVE COMPARATOR
Other: Transcutaneous vagus nerve stimulationOther: Deep breath exercise

Interventions

Transcutaneous vagus nerve stimulationOTHER

Investigation of the effects of vagus nerve stimulation on the autonomic and somatic systems together

autonomic functionsomatic function
Deep breath exerciseOTHER

Investigation of the effects of vagus nerve stimulation on the autonomic and somatic systems together

autonomic functionsomatic function

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • could read and write Turkish

You may not qualify if:

  • being 18 years or older having no known acute or chronic disease, and no previous treatment with vagus nerve stimulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Gelisim University

Istanbul, Avcılar, 34310, Turkey (Türkiye)

Location

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2024

First Posted

December 18, 2024

Study Start

February 27, 2022

Primary Completion

June 12, 2022

Study Completion

August 28, 2022

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)