[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491531":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":36,"responsibleParty":78,"collaborators":81,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":25,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":25,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Bakulev Scientific Center of Cardiovascular Surgery","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active TENS","ACTIVE_COMPARATOR","Active will be performed with using a TENS device with an ear clip attached to the tragus of the left ear (which is innervated by auricular branch of the vagus nerve) at 20 Hz, 200 μs at a current just below discomfort threshold.",[13],"Device: TENS",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham TENS","SHAM_COMPARATOR","Sham will be performed with using a TENS device with an ear clip attached to the left earlobe (which is devoid of vegas innervation) at 20 Hz, 200 μs at a current just below discomfort threshold.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","TENS","TENS stimulation will occur within 10 minutes. HRV parameters will be evaluated before stimulation initially at rest, in the first 5 minutes of stimulation, in the second 5 minutes of stimulation and after the end of stimulation.",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Vladimir Shvartz","Bakoulev Scientific Center for Cardiovascular Surgery","PRINCIPAL_INVESTIGATOR",[32],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","+79032619292","vashvarts@bakulev.ru",[37,54,67],{"facility":38,"status":39,"city":40,"state":25,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Federal Center for Cardiovascular Surgery (Astrakhan)","RECRUITING","Astrakhan","Russia","RU",{"type":44,"coordinates":45},"Point",[46,47],48.04076,46.34968,{"lat":47,"lon":46},[50],{"name":51,"role":33,"phone":52,"phoneExt":25,"email":53},"Soslan Enginoev","+79275764006","surgery-89@yandex.ru",{"facility":55,"status":39,"city":56,"state":25,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital","Krasnodar",{"type":44,"coordinates":58},[59,60],38.98178,45.04534,{"lat":60,"lon":59},[63],{"name":64,"role":33,"phone":65,"phoneExt":25,"email":66},"Sofia Kruchinova","+79189504597","skruchinova@mail.ru",{"facility":68,"status":39,"city":69,"state":25,"zip":70,"country":41,"countryCode":42,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Bakulev National Medical Research Center for Cardiovascular Surgery","Moscow","121552",{"type":44,"coordinates":72},[73,74],37.61781,55.75204,{"lat":74,"lon":73},[77],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},{"type":30,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Vladimir A Shvartz, MD","MD, DM, Professor",[82,83],{"name":55,"class":6},{"name":84,"class":85},"Astrakhan Federal Centre For Cardiac Surgery","OTHER","100491531","auricular-vagus-stimulation-and-heart-rate-variability-100491531",false,"NCT05680337","Auricular Vagus Stimulation and Heart Rate Variability","Transcutaneous Electrical Auricular Vagus Stimulation and Heart Rate Variability","Inclusion Criteria:\n\n* Sinus rhythm at the time of registration\n\nExclusion Criteria:\n\n* Frequent ventricular \u002F supraventricular extrasystole, 2d\u002F3d degree AV Block\n* Taking glucocorticosteroids in the last 1 month\n* Taking any antiarrhythmics, except beta blockers\n* Severe chronic renal or liver pathology",true,"ALL","18 Years","75 Years",{"count":98,"type":99},600,"ESTIMATED","INTERVENTIONAL",[102],"NA","Transcutaneous electrical stimulation of the auricular vagus nerve (TENS) is a promising method of neuromodulation of the autonomic nervous system in patients with various pathologies. The use of this method requires the determination of a reliable biomarker of successful activation of the vagus nerve using TENS. Currently, most studies focus on the assessment of heart rate variability (HRV) as a marker of the functioning of the autonomic nervous system.\n\nDespite the physiological justification of HRV as a biomarker for TENS, the data on the effects of TENS on HRV are ambiguous. In some studies, a significant decrease in the ratio of spectral characteristics (LF\u002FHF) in active TENS was found in comparison with fictitious stimulation (sham), which indicated an increase in the parasympathetic component of HRV. However, other studies have not revealed an increase in HRV.",[105,106],"Vagus Nerve Stimulation","Heart Rate Variability",[108,109,110,111,112,113,114,115,116,117,118,119,120],"auricular stimulation","auricular vagus nerve stimulation","heart rate","transcutaneous vagus nerve stimulation (TENS)","vagus nerve stimulation (VNS)","heart rate variability","power of high-frequency oscillations (HF)","power of low-frequency oscillations (LF)","power of very low frequency oscillations (VLF)","power of ultra-low frequency oscillations (ULF)","LF\u002FHF","index centralization (IC)","index of vegetative balance (IVB)","2025-06-17",{"date":123,"type":124},"2025-06-18","ACTUAL",{"date":126,"type":124},"2022-12-01",{"date":128,"type":99},"2026-07-01",{"name":5,"class":6},3]