Breathing ExercisesPhase 2NCT06531954
Breathing Exercises and Auricular Vagus Nerve Stimulation
A Phase 2 study testing Vagus nerve stimulation and Breathing exercise in people with Breathing Exercises and Auricular Vagus Nerve Stimulation, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Vagal modulation is achieved directly by transcutaneous auricular vagus nerve stimulation, whereas breathing exercises stimulate arterial baroreceptors. In this study, we aimed to compare these two methods, which have similar effects. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Breathing Exercises, Auricular Vagus Nerve Stimulation, Autonomic Nervous System
- What is being tested?
- Vagus nerve stimulation and Breathing exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2021to 1 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals between the ages of 18 and 35,
- without orthopedic disability,
- without any chronic disease and regular medication use,
- who had not smoked for the last year,
- who had no problems in reading, writing, or comprehension were included in our study.
Who cannot join
- active or chronic respiratory diseases and communication problems because they may adversely affect pulmonary function testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of Breathing Exercises and Auricular Vagus Nerve Stimulation Effects On Autonomic Nervous System Activity and Respiratory Functions In Healthy Adults
Introduction: Vagal modulation is achieved directly by transcutaneous auricular vagus nerve stimulation, whereas breathing exercises stimulate arterial baroreceptors. In this study, we aimed to compare these two methods, which have similar effects.
Methods: 88 healthy participants aged 18-35 were randomly divided into breathing exercises (Group BE) and vagus stimulation (Group VNS). Thoracic expansion exercise was performed in the BE group. In the VNS group, biphasic electrical stimulation was applied to both ears with a pulse width of 300 microseconds, frequency of 10 Hz, and 20 minutes. Pulmonary function tests were measured on the first and last day. Heart rate, systolic and diastolic blood pressure, RMSSD, PNN50, LF/HF, LF Power, and HF Power values were measured before and after each of the ten sessions for both groups.
- Being tested
- Vagus nerve stimulation, Breathing exercise
- Keywords
- Breathing Exercises, Autonomic Nervous System, Pulse Rate Variability, Respiratory Functions, Auricular Vagus Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerve stimulationDevice
Vagus nerve stimulation group: Vagus stimulation was applied bilaterally through the ear. taVNS was performed with the Vagustim device. The stimulation pulse width was 300 microseconds, the frequency was 10 Hz, and it was biphasic with a 20-minute duration. Electrodes were placed on the concha and tragus parts of the ear, and the current was increased through these electrodes until the participant felt pain.
Breathing exerciseBehavioural
Breathing exercise group: The content of breathing exercises was planned as thoracic expansion exercises. These exercises were applied to the lower, middle, and upper lobes in 3 sets of 3x10 (90 times breathing in one area) and lasted for an average of 20 minutes. Participants were asked to inhale as deeply as possible into the relevant area, hold their breath for 3 seconds, and then slowly exhale the entire breath.
| Study group | Role | What they receive |
|---|---|---|
| Breathing exercise group (BE) | Active comparator | The content of breathing exercises was planned as thoracic expansion exercises. These exercises were applied to the lower, middle, and upper lobes in 3 sets of 3x10 (90 times breathing in one area) and lasted for an average of 20 minutes. These exercises were first taught by the physiotherapist and performed under her supervision. Participants were asked to inhale as deeply as possible into the relevant area, hold their breath for 3 seconds, and then slowly exhale the entire breath. Receives: Behavioral: Breathing exercise |
| Vagus nerve stimulation group (VNS) | Experimental | Vagus stimulation was applied bilaterally through the ear. taVNS was performed with the Vagustim device. The stimulation pulse width was 300 microseconds, the frequency was 10 Hz, and it was biphasic with a 20-minute duration. Electrodes were placed on the concha and tragus parts of the ear, and the current was increased through these electrodes until the participant felt pain. When the participant felt pain, the intensity was reduced to a comfortable sensation. Receives: Device: Vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic nervous system activity
Autonomic measurements of each individual participating in the study before and after the intervention were performed with heart rate variability parameters. For this purpose, the Elite HRV device was used. The device has a finger sensor and an application compatible with the phone. Elite HRV application is a software that can synchronize with a personal monitor by collecting peak-to-peak intervals for instant analysis of pulse rate variability (PRV). In addition to all these assessments, blood pressure measurements of the participants were also evaluated using an Omron M2 electronic sphygmomanometer on the right arm.
Measured: pre-intervention, immediately after-intervention
Pulmonary Function. Forced expiratory volume in the first second (FEV1)
Participants in both groups underwent pulmonary function test evaluation on the first and last day. Since the study was conducted in healthy individuals, it was deemed appropriate to look at the pulmonary function test before and after exertion to see possible changes. Medwelt SP10 spirometer was used for pulmonary function tests in our study. Each individual was measured in a sitting position using a separate mouthpiece.
Measured: pre-intervention, immediately after-intervention
Pulmonary Function. Forced vital capacity (FVC)
Participants in both groups underwent pulmonary function test evaluation on the first and last day. Since the study was conducted in healthy individuals, it was deemed appropriate to look at the pulmonary function test before and after exertion to see possible changes. Medwelt SP10 spirometer was used for pulmonary function tests in our study. Each individual was measured in a sitting position using a separate mouthpiece.
Measured: pre-intervention, immediately after-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start2 Jan 2021
- Primary completion3 Jan 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breathing ExercisesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Our study was conducted as a randomized prospective study. In both groups, the interventions were performed for ten sessions for two weeks, five days a week. In both groups, heart rate variability, heart rate, and blood tension were measured before and after each session, and the pulmonary function test was evaluated the day before and the day after the ten sessions of applications.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gulay karacaoglu, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531954
- Sponsor's protocol ID
- Nervusvagus
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our study was conducted as a randomized prospective study. In both groups, the interventions were performed for ten sessions for two weeks, five days a week. In both groups, heart rate variability, heart rate, and blood tension were measured before and after each session, and the pulmonary function test was evaluated the day before and the day after the ten sessions of applications. Since the study was conducted in healthy participants, pulmonary function tests were examined Before and after aerobic training to see possible changes. The training on the treadmill consisted of 5-minute warm-ups, 20 minutes of loading, and five 5-minute cool-down periods. Participants performed warm-up and cool-down periods at a treadmill speed of 4km/h. After determining the maximum heart rate according to the 220-age formula, the loading intensity was performed at 60% of this value \[4\]. Intergroup comparisons were made as a result of the evaluations in both groups.
Publications
Hatik SH, Arslan M, Demirbilek O, Ozden AV. The effect of transcutaneous auricular vagus nerve stimulation on cycling ergometry and recovery in healthy young individuals. Brain Behav. 2023 Dec;13(12):e3332. doi: 10.1002/brb3.3332. Epub 2023 Nov 16.
PubMed 37974551
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Breathing Exercises and Auricular Vagus Nerve Stimulation Effects On Autonomic Nervous System Activity and Respiratory Functions In Healthy Adults
- ClinicalTrials.gov ID
- NCT06531954
- Acronym / sponsor ID
- Nervusvagus
- Keywords
- Breathing Exercises, Autonomic Nervous System, Pulse Rate Variability, Respiratory Functions, Auricular Vagus Nerve Stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Vagal modulation is achieved directly by transcutaneous auricular vagus nerve stimulation, whereas breathing exercises stimulate arterial baroreceptors. In this study, we aimed to compare these two methods, which have similar effects.
Methods: 88 healthy participants aged 18-35 were randomly divided into breathing exercises (Group BE) and vagus stimulation (Group VNS). Thoracic expansion exercise was performed in the BE group. In the VNS group, biphasic electrical stimulation was applied to both ears with a pulse width of 300 microseconds, frequency of 10 Hz, and 20 minutes. Pulmonary function tests were measured on the first and last day. Heart rate, systolic and diastolic blood pressure, RMSSD, PNN50, LF/HF, LF Power, and HF Power values were measured before and after each of the ten sessions for both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Our study was conducted as a randomized prospective study. In both groups, the interventions were performed for ten sessions for two weeks, five days a week. In both groups, heart rate variability, heart rate, and blood tension were measured before and after each session, and the pulmonary function test was evaluated the day before and the day after the ten sessions of applications.
| Arm | Type | Receives |
|---|---|---|
| Breathing exercise group (BE) | Active comparator | Behavioral: Breathing exerciseThe content of breathing exercises was planned as thoracic expansion exercises. These exercises were applied to the lower, middle, and upper lobes in 3 sets of 3x10 (90 times breathing in one area) and lasted for an average of 20 minutes. These exercises were first taught by the physiotherapist and performed under her supervision. Participants were asked to inhale as deeply as possible into the relevant area, hold their breath for 3 seconds, and then slowly exhale the entire breath. |
| Vagus nerve stimulation group (VNS) | Experimental | Device: Vagus nerve stimulationVagus stimulation was applied bilaterally through the ear. taVNS was performed with the Vagustim device. The stimulation pulse width was 300 microseconds, the frequency was 10 Hz, and it was biphasic with a 20-minute duration. Electrodes were placed on the concha and tragus parts of the ear, and the current was increased through these electrodes until the participant felt pain. When the participant felt pain, the intensity was reduced to a comfortable sensation. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy individuals between the ages of 18 and 35,
- without orthopedic disability,
- without any chronic disease and regular medication use,
- who had not smoked for the last year,
- who had no problems in reading, writing, or comprehension were included in our study.
Key exclusion criteria (1 listed)
- active or chronic respiratory diseases and communication problems because they may adversely affect pulmonary function testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus nerve stimulationVagus nerve stimulation group: Vagus stimulation was applied bilaterally through the ear. taVNS was performed with the Vagustim device. The stimulation pulse width was 300 microseconds, the frequency was 10 Hz, and it was biphasic with a 20-minute duration. Electrodes were placed on the concha and tragus parts of the ear, and the current was increased through these electrodes until the participant felt pain. | Device | Vagus nerve stimulation group (VNS) |
| Breathing exerciseBreathing exercise group: The content of breathing exercises was planned as thoracic expansion exercises. These exercises were applied to the lower, middle, and upper lobes in 3 sets of 3x10 (90 times breathing in one area) and lasted for an average of 20 minutes. Participants were asked to inhale as deeply as possible into the relevant area, hold their breath for 3 seconds, and then slowly exhale the entire breath. | Behavioural | Breathing exercise group (BE) |
Primary outcome
Autonomic nervous system activity
Time frame: pre-intervention, immediately after-intervention
Autonomic measurements of each individual participating in the study before and after the intervention were performed with heart rate variability parameters. For this purpose, the Elite HRV device was used. The device has a finger sensor and an application compatible with the phone. Elite HRV application is a software that can synchronize with a personal monitor by collecting peak-to-peak intervals for instant analysis of pulse rate variability (PRV). In addition to all these assessments, blood pressure measurements of the participants were also evaluated using an Omron M2 electronic sphygmomanometer on the right arm.
Pulmonary Function. Forced expiratory volume in the first second (FEV1)
Time frame: pre-intervention, immediately after-intervention
Participants in both groups underwent pulmonary function test evaluation on the first and last day. Since the study was conducted in healthy individuals, it was deemed appropriate to look at the pulmonary function test before and after exertion to see possible changes. Medwelt SP10 spirometer was used for pulmonary function tests in our study. Each individual was measured in a sitting position using a separate mouthpiece.
Pulmonary Function. Forced vital capacity (FVC)
Time frame: pre-intervention, immediately after-intervention
Participants in both groups underwent pulmonary function test evaluation on the first and last day. Since the study was conducted in healthy individuals, it was deemed appropriate to look at the pulmonary function test before and after exertion to see possible changes. Medwelt SP10 spirometer was used for pulmonary function tests in our study. Each individual was measured in a sitting position using a separate mouthpiece.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Results publication: PubMed 37974551Hatik SH, Arslan M, Demirbilek O, Ozden AV. The effect of transcutaneous auricular vagus nerve stimulation on cycling ergometry and recovery in healthy young individuals. Brain Behav. 2023 Dec;13(12):e3332. doi: 10.1002/brb3.3332. Epub 2023 Nov 16.
- Individual participant dataSharing planned: Yes. Our study was conducted as a randomized prospective study. In both groups, the interventions were performed for ten sessions for two weeks, five days a week. In both groups, heart rate variability, heart rate, and blood tension were measured before and after each session, and the pulmonary function test was evaluated the day before and the day after the ten sessions of applications. Since the study was conducted in healthy participants, pulmonary function tests were examined Before and after aerobic training to see possible changes. The training on the treadmill consisted of 5-minute warm-ups, 20 minutes of loading, and five 5-minute cool-down periods. Participants performed warm-up and cool-down periods at a treadmill speed of 4km/h. After determining the maximum heart rate according to the 220-age formula, the loading intensity was performed at 60% of this value [4]. Intergroup comparisons were made as a result of the evaluations in both groups.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vagus nerve stimulation and Breathing exercise in people with Breathing Exercises and Auricular Vagus Nerve Stimulation, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic nervous system activity (time frame: pre-intervention, immediately after-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06531954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.