HealthyTAVNSCERNCT05778058
The Effect of Vagus Nerve Stimulation on Cycling Ergometry and Recovery
A study testing Unilateral Stimulation, Bilateral Stimulation and Bicycle Ergometer Test in people with Healthy and Sports Physical Therapy, run by Sinop University at 1 site in Turkey (Türkiye).
Trial summary
It is aIt is aimed to examine the possible benefits and effects of the use of Transcutaneous Auricular Vagus Nerve Stimulation to be applied in healthy individuals for sportive purposes on recovery and sportive performance level. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Sports Physical Therapy, Activity, Motor
- What is being tested?
- Unilateral Stimulation, Bilateral Stimulation and Bicycle Ergometer Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Aug 2022
- Phase
- Interventional
- 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 18-35,
- Willingness to participate in the study
- Having signed the informed consent form
Who cannot join
- Cases do not want to continue the study.
- Having regular sports habits or starting in the working process,
- Having a disease related to the respiratory system and starting to use drugs
- Having a disease related to the cardiac system and starting to use drugs
- Presence of any chronic disease and using a drug related to it
Trial locations and contacts
1 site in 1 country.
About this study
Official title: he Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Cycling Ergometry and Recovery in Healthy Young Individuals
It is aIt is aimed to examine the possible benefits and effects of the use of Transcutaneous Auricular Vagus Nerve Stimulation to be applied in healthy individuals for sportive purposes on recovery and sportive performance level.
Read the detailed description
The 90 people between the ages of 18-35 will be included in the study. Each participant will be randomly divided into 3 groups to be homogeneous after the necessary calculations are made by evaluating with age, gender, weight, height and body mass index before starting the study.
The groups are; It will be in the form of Unilateral Stimulation (n=30), Bilateral Stimulation (n=30) and Bilateral Sham Stimulation (n=30) groups.
After the initial assessment, participants in all groups will be asked to do 30 minutes of cycling exercise at maximum performance under the same wattage load. Cycling will be re-evaluated after exercise. After the assessment is complete, stimulation will be given with Vagustim for 20 minutes non-invasively. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated.
After the pain and fatigue rating scale, the evaluation will be completed by determining the lactate level in the blood with the Lactat Scout. Vagus nerve stimulation will be applied with the Vagustim device for 20 minutes, keeping it biphasic, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current where the participant feels the current comfortably.
At the end of the Cycling Ergometer Test and Vagus nerve stimulation, the Autonomic Nervous System, pulse and blood pressure will be evaluated with Polar H10 within 5 minutes.
- Conditions
- Healthy, Sports Physical Therapy, Activity, Motor
- Being tested
- Unilateral Stimulation, Bilateral Stimulation, Bilateral Sham Stimulation, Bicycle Ergometer Test, Lactat Scout
- Keywords
- Vagus Nerve Stimulation, Physiological Parameters, Recovery, Cycle Ergometer Test, Transcutaneous Auricular
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral StimulationDevice
With the Vagustim device, vagus nerve stimulation will be applied in one ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably.
Bilateral StimulationDevice
With the Vagustim device, vagus nerve stimulation will be applied in one ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably.
Bilateral Sham StimulationDevice
Participants were shown that the device was working, but no current was given.
Bicycle Ergometer TestDiagnostic test
Participants in this group were asked to perform bicycle exercise with maximum performance under 30 watts for 30 minutes.
Lactat ScoutDiagnostic test
For lactic acid analysis measurement, the middle fingertip of the athlete is disinfected with an alcohol swab and a blood sample is taken by puncturing the finger.The measuring range is 0.5 - 0.25 mmol/L.
Polar H10Diagnostic test
RR times transferred to computer with Polar H10 are used in heart rate variability analysis. Heart rate data will be transferred to the Kubios program and heart rate variability parameters will be calculated and data on the autonomic nervous system (RMSSD, PNS index, Stress index, SNS index, pNN50, Power LF, Power HF and LF/HF ratio) will be obtained.
Vagustim DeviceDevice
Vagustim Health Technologies Vagus stimulator device is used for this experiment.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Stimulation | Experimental | After evaluating with 7 different parameters on the first, second, third and fourth days of the protocol, the participants in all groups will be asked to do cycling exercise with maximum performance for 30 minutes under the same wattage load.
It will be re-evaluated after the cycling exercise application. After the assessment is complete, stimulation will be given with Vagustim non-invasively for 30 minutes. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated.
With the Vagustim device, vagus nerve stimulation will be applied in one ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably. Receives: Device: Unilateral Stimulation; Diagnostic Test: Bicycle Ergometer Test; Diagnostic Test: Lactat Scout; Diagnostic Test: Polar H10; Device: Vagustim Device |
| Bilateral Stimulation | Experimental | After evaluating with 7 different parameters on the first, second, third and fourth days of the protocol, the participants in all groups will be asked to do cycling exercise with maximum performance for 30 minutes under the same wattage load.
It will be re-evaluated after the cycling exercise application. After the assessment is complete, stimulation will be given with Vagustim non-invasively for 20minutes. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated.
With the Vagustim device, vagus nerve stimulation will be applied in bilateral ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably. Receives: Device: Bilateral Stimulation; Diagnostic Test: Bicycle Ergometer Test; Diagnostic Test: Lactat Scout; Diagnostic Test: Polar H10; Device: Vagustim Device |
| Bilateral Sham Stimulation | Sham comparator | After evaluating with 7 different parameters on the first, second, third and fourth days of the protocol, the participants in all groups will be asked to do cycling exercise with maximum performance for 30 minutes under the same wattage load. Bisiklet egzersiz uygulaması sonrasında tekrar değerlendirilecektir.
It will be re-evaluated after the cycling exercise. After the assessment is complete, sham stimulation with Vagustim for 20 minutes will be given non-invasively. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated. Receives: Device: Bilateral Sham Stimulation; Diagnostic Test: Bicycle Ergometer Test; Diagnostic Test: Lactat Scout; Diagnostic Test: Polar H10; Device: Vagustim Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of autonomous parameters
Systolic / diastolic blood pressure (mmHg) will be measured with the Braun sphygmomanometer.
Measured: In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.
Numerical Fatigue Rating Scale
The fatigue NRS is a patient-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing 'no fatigue' and 10 representing 'as bad as you can imagine'. Patients are asked to 'please rate your fatigue (weariness, tiredness) by selecting the number.
Measured: In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.
Numerical Pain Rating Scale
Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain.
Measured: In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.
Bicycle Ergometer Test
All participants will be asked to perform cycling exercise at maximum performance for 30 minutes under a load of 30 watts. Then, the distance (meters) covered during the exercise will be evaluated for the sportive performance of the participants.
Measured: It was measured 4 times in aggregation in the 4-day protocol.
Lactat Scout
For lactic acid analysis measurement, the middle fingertip of the athlete is disinfected with an alcohol swab and a blood sample is taken by puncturing the finger.The measuring range is 0.5 - 0.25 mmol/L.
Measured: It was measured 4 times in total on the 1st and 2nd days of the 4-day protocol.
Polar H10
RR times transferred to computer with Polar H10 are used in heart rate variability analysis. Heart rate data will be transferred to the Kubios program and heart rate variability parameters will be calculated and data on the autonomic nervous system (RMSSD, PNS index, Stress index, SNS index, pNN50, Power LF, Power HF and LF/HF ratio) will be obtained.
Measured: It was measured 4 times in total on the 1st and 2nd days of the 4-day protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Mar 2022
- Primary completion1 Jun 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 90 healthy young individuals were included in the study. Participants were randomly divided into 3 groups as unilateral (n=30, 15 female, 15 male), bilateral (n=30, 15 female, 15 male) and bilateral sham (n=30, 15 female, 15 male) groups. ). The cycling exercise was performed at maximum performance for 30 minutes under the same wattage load. Non-invasive ear stimulation was performed with the Vagustim device according to the participant groups. Pulse, systolic and diastolic blood pressure, distance, pain, fatigue, lactic acid level and autonomic nervous system were evaluated before, after and at the end of cycling exercise. Oneway Anova test and Kruskal Wallis test were used between groups. Dunn's test was used to determine the group that caused the difference. Analysis of variance was used for repeated measurements, Bonferroni test and Friedman test were used for in-group comparisons. Significance was evaluated at the p\<0.05 level.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinop University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SEFA HAKTAN HATIK, Asst. Prof, Study director, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778058
- Sponsor's protocol ID
- VNS003
- Acronym
- TAVNSCER
- Status last verified
- Mar 2023
- First submitted
- 15 Sep 2021
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- he Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Cycling Ergometry and Recovery in Healthy Young Individuals
- ClinicalTrials.gov ID
- NCT05778058
- Acronym / sponsor ID
- TAVNSCER / VNS003
- Conditions
- Healthy, Sports Physical Therapy, Activity, Motor
- Keywords
- Vagus Nerve Stimulation, Physiological Parameters, Recovery, Cycle Ergometer Test, Transcutaneous Auricular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sinop UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 21 Mar 2023 (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.
It is aIt is aimed to examine the possible benefits and effects of the use of Transcutaneous Auricular Vagus Nerve Stimulation to be applied in healthy individuals for sportive purposes on recovery and sportive performance level.
Detailed description
The 90 people between the ages of 18-35 will be included in the study. Each participant will be randomly divided into 3 groups to be homogeneous after the necessary calculations are made by evaluating with age, gender, weight, height and body mass index before starting the study.
The groups are; It will be in the form of Unilateral Stimulation (n=30), Bilateral Stimulation (n=30) and Bilateral Sham Stimulation (n=30) groups.
After the initial assessment, participants in all groups will be asked to do 30 minutes of cycling exercise at maximum performance under the same wattage load. Cycling will be re-evaluated after exercise. After the assessment is complete, stimulation will be given with Vagustim for 20 minutes non-invasively. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated.
After the pain and fatigue rating scale, the evaluation will be completed by determining the lactate level in the blood with the Lactat Scout. Vagus nerve stimulation will be applied with the Vagustim device for 20 minutes, keeping it biphasic, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current where the participant feels the current comfortably.
At the end of the Cycling Ergometer Test and Vagus nerve stimulation, the Autonomic Nervous System, pulse and blood pressure will be evaluated with Polar H10 within 5 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 90 healthy young individuals were included in the study. Participants were randomly divided into 3 groups as unilateral (n=30, 15 female, 15 male), bilateral (n=30, 15 female, 15 male) and bilateral sham (n=30, 15 female, 15 male) groups. ). The cycling exercise was performed at maximum performance for 30 minutes under the same wattage load. Non-invasive ear stimulation was performed with the Vagustim device according to the participant groups. Pulse, systolic and diastolic blood pressure, distance, pain, fatigue, lactic acid level and autonomic nervous system were evaluated before, after and at the end of cycling exercise. Oneway Anova test and Kruskal Wallis test were used between groups. Dunn's test was used to determine the group that caused the difference. Analysis of variance was used for repeated measurements, Bonferroni test and Friedman test were used for in-group comparisons. Significance was evaluated at the p<0.05 level.
| Arm | Type | Receives |
|---|---|---|
| Unilateral Stimulation | Experimental | Device: Unilateral Stimulation, Diagnostic Test: Bicycle Ergometer Test, Diagnostic Test: Lactat Scout, Diagnostic Test: Polar H10, Device: Vagustim DeviceAfter evaluating with 7 different parameters on the first, second, third and fourth days of the protocol, the participants in all groups will be asked to do cycling exercise with maximum performance for 30 minutes under the same wattage load. It will be re-evaluated after the cycling exercise application. After the assessment is complete, stimulation will be given with Vagustim non-invasively for 30 minutes. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated. With the Vagustim device, vagus nerve stimulation will be applied in one ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably. |
| Bilateral Stimulation | Experimental | Device: Bilateral Stimulation, Diagnostic Test: Bicycle Ergometer Test, Diagnostic Test: Lactat Scout, Diagnostic Test: Polar H10, Device: Vagustim DeviceAfter evaluating with 7 different parameters on the first, second, third and fourth days of the protocol, the participants in all groups will be asked to do cycling exercise with maximum performance for 30 minutes under the same wattage load. It will be re-evaluated after the cycling exercise application. After the assessment is complete, stimulation will be given with Vagustim non-invasively for 20minutes. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated. With the Vagustim device, vagus nerve stimulation will be applied in bilateral ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably. |
| Bilateral Sham Stimulation | Sham comparator | Device: Bilateral Sham Stimulation, Diagnostic Test: Bicycle Ergometer Test, Diagnostic Test: Lactat Scout, Diagnostic Test: Polar H10, Device: Vagustim DeviceAfter evaluating with 7 different parameters on the first, second, third and fourth days of the protocol, the participants in all groups will be asked to do cycling exercise with maximum performance for 30 minutes under the same wattage load. Bisiklet egzersiz uygulaması sonrasında tekrar değerlendirilecektir. It will be re-evaluated after the cycling exercise. After the assessment is complete, sham stimulation with Vagustim for 20 minutes will be given non-invasively. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy individuals between the ages of 18-35,
- Willingness to participate in the study
- Having signed the informed consent form
Key exclusion criteria (5 listed)
- Cases do not want to continue the study.
- Having regular sports habits or starting in the working process,
- Having a disease related to the respiratory system and starting to use drugs
- Having a disease related to the cardiac system and starting to use drugs
- Presence of any chronic disease and using a drug related to it
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 |
|---|---|---|
| Unilateral StimulationWith the Vagustim device, vagus nerve stimulation will be applied in one ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably. | Device | Unilateral Stimulation |
| Bilateral StimulationWith the Vagustim device, vagus nerve stimulation will be applied in one ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably. | Device | Bilateral Stimulation |
| Bilateral Sham StimulationParticipants were shown that the device was working, but no current was given. | Device | Bilateral Sham Stimulation |
| Bicycle Ergometer TestParticipants in this group were asked to perform bicycle exercise with maximum performance under 30 watts for 30 minutes. | Diagnostic test | Bilateral Sham Stimulation, Bilateral Stimulation, Unilateral Stimulation |
| Lactat ScoutFor lactic acid analysis measurement, the middle fingertip of the athlete is disinfected with an alcohol swab and a blood sample is taken by puncturing the finger.The measuring range is 0.5 - 0.25 mmol/L. | Diagnostic test | Bilateral Sham Stimulation, Bilateral Stimulation, Unilateral Stimulation |
| Polar H10RR times transferred to computer with Polar H10 are used in heart rate variability analysis. Heart rate data will be transferred to the Kubios program and heart rate variability parameters will be calculated and data on the autonomic nervous system (RMSSD, PNS index, Stress index, SNS index, pNN50, Power LF, Power HF and LF/HF ratio) will be obtained. | Diagnostic test | Bilateral Sham Stimulation, Bilateral Stimulation, Unilateral Stimulation |
| Vagustim DeviceVagustim Health Technologies Vagus stimulator device is used for this experiment. | Device | Bilateral Sham Stimulation, Bilateral Stimulation, Unilateral Stimulation |
Primary outcome
Evaluation of autonomous parameters
Time frame: In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.
Systolic / diastolic blood pressure (mmHg) will be measured with the Braun sphygmomanometer.
Numerical Fatigue Rating Scale
Time frame: In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.
The fatigue NRS is a patient-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing 'no fatigue' and 10 representing 'as bad as you can imagine'. Patients are asked to 'please rate your fatigue (weariness, tiredness) by selecting the number.
Numerical Pain Rating Scale
Time frame: In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.
Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain.
Bicycle Ergometer Test
Time frame: It was measured 4 times in aggregation in the 4-day protocol.
All participants will be asked to perform cycling exercise at maximum performance for 30 minutes under a load of 30 watts. Then, the distance (meters) covered during the exercise will be evaluated for the sportive performance of the participants.
Lactat Scout
Time frame: It was measured 4 times in total on the 1st and 2nd days of the 4-day protocol.
For lactic acid analysis measurement, the middle fingertip of the athlete is disinfected with an alcohol swab and a blood sample is taken by puncturing the finger.The measuring range is 0.5 - 0.25 mmol/L.
Polar H10
Time frame: It was measured 4 times in total on the 1st and 2nd days of the 4-day protocol.
RR times transferred to computer with Polar H10 are used in heart rate variability analysis. Heart rate data will be transferred to the Kubios program and heart rate variability parameters will be calculated and data on the autonomic nervous system (RMSSD, PNS index, Stress index, SNS index, pNN50, Power LF, Power HF and LF/HF ratio) will be obtained.
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 21 Mar 2023.
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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.
SEFA HAKTAN HATIK, Asst. Prof study director
Sinop University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral Stimulation, Bilateral Stimulation and Bicycle Ergometer Test in people with Healthy and Sports Physical Therapy, run by Sinop University 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 3 inclusion and 5 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 21 Mar 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Evaluation of autonomous parameters (time frame: In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2023.