Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT06740032
Status:
COMPLETED
Last Update Posted:
2024-12-18
First Post:
2024-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Acute Effects of Auricular Vagus Nerve Stimulation and Deep Breathing Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2024-11-29', 'studyFirstSubmitQcDate': '2024-12-13', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HRV results', 'timeFrame': '5 minutes', 'description': 'Measuring autonomic values for 5 minutes'}, {'measure': 'Muscle Natural Oscillation Frequency', 'timeFrame': '5 minutes', 'description': 'Biomechanical measurements of specific muscles'}, {'measure': 'Muscle Dynamic Stiffness [N/m]', 'timeFrame': '5 minutes', 'description': 'measured using the myoton device'}, {'measure': 'Mechanical Stress Relaxation Time [ms]', 'timeFrame': '5 minutes', 'description': 'measured using the myoton device'}], 'secondaryOutcomes': [{'measure': 'Perceived stress scale', 'timeFrame': '5 minutes', 'description': 'Evaluation of stress levels with the specified questionnaire'}, {'measure': 'Pulse rate', 'timeFrame': '5 minutes', 'description': 'Measuring with a sphygmomanometer'}, {'measure': 'blood pressure', 'timeFrame': '5 minutes', 'description': 'Measuring blood pressure with a sphygmomanometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Auricular vagus nerve stimulation', 'deep breathing exercises'], 'conditions': ['Vagus Nerve Stimulations']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://tez.yok.gov.tr/UlusalTezMerkezi/TezGoster?key=j_Fjwp4JS4mk97Puqti8rkiC2ELk2iQRp4Md6hu2HSMgdGSsqnEHfw2Ulqyn3nfW', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to investigate whether vagus stimulation and breathing exercises are more effective in healthy adults.\n\nAre 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* could read and write Turkish\n\nExclusion Criteria:\n\n* being 18 years or older having no known acute or chronic disease, and no previous treatment with vagus nerve stimulation'}, 'identificationModule': {'nctId': 'NCT06740032', 'briefTitle': 'Comparison of the Acute Effects of Auricular Vagus Nerve Stimulation and Deep Breathing Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Gelisim University'}, 'officialTitle': 'Comparison of the Acute Effects of Auricular Vagus Nerve Stimulation and Deep Breathing Exercise on the Autonomic Nervous System Activity and Biomechanical Properties of the Muscle in Healthy People', 'orgStudyIdInfo': {'id': 'VNS06.01.2022/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'autonomic function', 'interventionNames': ['Other: Transcutaneous vagus nerve stimulation', 'Other: Deep breath exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'somatic function', 'interventionNames': ['Other: Transcutaneous vagus nerve stimulation', 'Other: Deep breath exercise']}], 'interventions': [{'name': 'Transcutaneous vagus nerve stimulation', 'type': 'OTHER', 'description': 'Investigation of the effects of vagus nerve stimulation on the autonomic and somatic systems together', 'armGroupLabels': ['autonomic function', 'somatic function']}, {'name': 'Deep breath exercise', 'type': 'OTHER', 'description': 'Investigation of the effects of vagus nerve stimulation on the autonomic and somatic systems together', 'armGroupLabels': ['autonomic function', 'somatic function']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34310', 'city': 'Istanbul', 'state': 'Avcılar', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Gelisim University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Gelisim University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bahçeşehir University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}