Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT05778058
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2021-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Vagus Nerve Stimulation on Cycling Ergometry and Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2023-03-08', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of autonomous parameters', 'timeFrame': 'In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.', 'description': 'Systolic / diastolic blood pressure (mmHg) will be measured with the Braun sphygmomanometer.'}, {'measure': 'Numerical Fatigue Rating Scale', 'timeFrame': 'In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.', 'description': "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."}, {'measure': 'Numerical Pain Rating Scale', 'timeFrame': 'In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.', 'description': '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.'}, {'measure': 'Bicycle Ergometer Test', 'timeFrame': 'It was measured 4 times in aggregation in the 4-day protocol.', 'description': '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.'}, {'measure': 'Lactat Scout', 'timeFrame': 'It was measured 4 times in total on the 1st and 2nd days of the 4-day protocol.', 'description': '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.'}, {'measure': 'Polar H10', 'timeFrame': 'It was measured 4 times in total on the 1st and 2nd days of the 4-day protocol.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vagus Nerve Stimulation', 'Physiological Parameters', 'Recovery', 'Cycle Ergometer Test', 'Transcutaneous Auricular'], 'conditions': ['Healthy', 'Sports Physical Therapy', 'Activity, Motor']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe groups are; It will be in the form of Unilateral Stimulation (n=30), Bilateral Stimulation (n=30) and Bilateral Sham Stimulation (n=30) groups.\n\nAfter 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.\n\nAfter 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.\n\nAt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy individuals between the ages of 18-35,\n* Willingness to participate in the study\n* Having signed the informed consent form\n\nExclusion Criteria:\n\n* Cases do not want to continue the study.\n* Having regular sports habits or starting in the working process,\n* Having a disease related to the respiratory system and starting to use drugs\n* Having a disease related to the cardiac system and starting to use drugs\n* Presence of any chronic disease and using a drug related to it'}, 'identificationModule': {'nctId': 'NCT05778058', 'acronym': 'TAVNSCER', 'briefTitle': 'The Effect of Vagus Nerve Stimulation on Cycling Ergometry and Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Sinop University'}, 'officialTitle': 'he Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Cycling Ergometry and Recovery in Healthy Young Individuals', 'orgStudyIdInfo': {'id': 'VNS003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unilateral Stimulation', 'description': '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.\n\nIt 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.\n\nWith 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.', 'interventionNames': ['Device: Unilateral Stimulation', 'Diagnostic Test: Bicycle Ergometer Test', 'Diagnostic Test: Lactat Scout', 'Diagnostic Test: Polar H10', 'Device: Vagustim Device']}, {'type': 'EXPERIMENTAL', 'label': 'Bilateral Stimulation', 'description': '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.\n\nIt 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.\n\nWith 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.', 'interventionNames': ['Device: Bilateral Stimulation', 'Diagnostic Test: Bicycle Ergometer Test', 'Diagnostic Test: Lactat Scout', 'Diagnostic Test: Polar H10', 'Device: Vagustim Device']}, {'type': 'SHAM_COMPARATOR', 'label': 'Bilateral Sham Stimulation', 'description': '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.\n\nIt 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.', 'interventionNames': ['Device: Bilateral Sham Stimulation', 'Diagnostic Test: Bicycle Ergometer Test', 'Diagnostic Test: Lactat Scout', 'Diagnostic Test: Polar H10', 'Device: Vagustim Device']}], 'interventions': [{'name': 'Unilateral Stimulation', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Unilateral Stimulation']}, {'name': 'Bilateral Stimulation', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Bilateral Stimulation']}, {'name': 'Bilateral Sham Stimulation', 'type': 'DEVICE', 'description': 'Participants were shown that the device was working, but no current was given.', 'armGroupLabels': ['Bilateral Sham Stimulation']}, {'name': 'Bicycle Ergometer Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants in this group were asked to perform bicycle exercise with maximum performance under 30 watts for 30 minutes.', 'armGroupLabels': ['Bilateral Sham Stimulation', 'Bilateral Stimulation', 'Unilateral Stimulation']}, {'name': 'Lactat Scout', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Bilateral Sham Stimulation', 'Bilateral Stimulation', 'Unilateral Stimulation']}, {'name': 'Polar H10', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Bilateral Sham Stimulation', 'Bilateral Stimulation', 'Unilateral Stimulation']}, {'name': 'Vagustim Device', 'type': 'DEVICE', 'description': 'Vagustim Health Technologies Vagus stimulator device is used for this experiment.', 'armGroupLabels': ['Bilateral Sham Stimulation', 'Bilateral Stimulation', 'Unilateral Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sinop', 'country': 'Turkey (Türkiye)', 'facility': 'Sefa Haktan Hatik', 'geoPoint': {'lat': 42.02683, 'lon': 35.16253}}], 'overallOfficials': [{'name': 'SEFA HAKTAN HATIK, Asst. Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sinop University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinop University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}