[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614033":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":41,"centralContacts":41,"locations":58,"responsibleParty":71,"collaborators":41,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":41,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":101,"overallStatus":107,"whyStopped":41,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Sinop University","OTHER",[8,14,20,25,30],{"label":9,"type":10,"description":11,"interventionNames":12},"1 - Sham (0 Hz)","SHAM_COMPARATOR","Intervention Type: Pulsetto FIT™ tcVNS Device Intervention Name: Sham tcVNS Description: Device placed on bilateral cervical region; no electrical current delivered.\n\nDose: 10 minutes",[13],"Device: Pulsetto FIT™ - Sham tcVNS",{"label":15,"type":16,"description":17,"interventionNames":18},"2 - 10 Hz tcVNS","EXPERIMENTAL","Intervention Type:Pulsetto FIT™ tcVNS Device Intervention Name: tcVNS (10 Hz) Description: Bilateral cervical stimulation at 10 Hz, 250 μs pulse width. Duration: 10 minutes",[19],"Device: Pulsetto FIT™ - tcVNS 10 Hz",{"label":21,"type":16,"description":22,"interventionNames":23},"3 - tcVNS 25 Hz","Intervention Type:Pulsetto FIT™ tcVNS Device Intervention Name: tcVNS (25 Hz) Description: Bilateral cervical stimulation at 25 Hz, 250 μs pulse width. Duration: 10 minutes",[24],"Device: Pulsetto FIT™ - tcVNS 25 Hz",{"label":26,"type":16,"description":27,"interventionNames":28},"4 - tcVNS 50 Hz","Intervention Type:Pulsetto FIT™ tcVNS Device Intervention Name: tcVNS (50 Hz) Description: Bilateral cervical stimulation at 50 Hz, 250 μs pulse width. Duration: 10 minutes",[29],"Device: Pulsetto FIT™ - tcVNS 50 Hz",{"label":31,"type":16,"description":32,"interventionNames":33},"5 - tcVNS 100 Hz","Intervention Type:Pulsetto FIT™ tcVNS Device Intervention Name: tcVNS (100 Hz) Description: Bilateral cervical stimulation at 100 Hz, 250 μs pulse width. Duration: 10 minutes",[34],"Device: Pulsetto FIT™ - tcVNS 100 Hz",[36,42,46,50,54],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DEVICE","Pulsetto FIT™ - Sham tcVNS","The Pulsetto FIT™ device is placed bilaterally on the cervical region (posterior margin of the sternocleidomastoid muscle).\n\nIn the sham condition, the device displays normal operational lights but delivers no electrical stimulation (0 Hz; inactive mode).\n\nThis condition is used for blinding and as the control comparator. Dose: 10 minutes",[9],null,{"type":37,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"Pulsetto FIT™ - tcVNS 10 Hz","Bilateral transcutaneous cervical vagus nerve stimulation delivered via the Pulsetto FIT™ device at 10 Hz, 250 µs pulse width.\n\nCurrent intensity adjusted to a mild, non-painful tingling sensation, individualized for each participant.\n\nDose: 10 minutes",[15],{"type":37,"name":47,"description":48,"armGroupLabels":49,"otherNames":41},"Pulsetto FIT™ - tcVNS 25 Hz","Bilateral tcVNS using the Pulsetto FIT™ device at 25 Hz, 250 µs pulse width. Stimulation intensity set at a comfortable sensory level. Dose: 10 minutes",[21],{"type":37,"name":51,"description":52,"armGroupLabels":53,"otherNames":41},"Pulsetto FIT™ - tcVNS 50 Hz","Bilateral cervical vagus nerve stimulation via Pulsetto FIT™ at 50 Hz, 250 µs pulse width.\n\nIntensity adjusted to a tolerable sensory level without discomfort. Dose: 10 minutes",[26],{"type":37,"name":55,"description":56,"armGroupLabels":57,"otherNames":41},"Pulsetto FIT™ - tcVNS 100 Hz","Bilateral tcVNS delivered with the Pulsetto FIT™ device at 100 Hz, 250 µs pulse width.\n\nHighest stimulation frequency used in this protocol; current intensity individualized per participant comfort.\n\nDose: 10 minutes",[31],[59],{"facility":60,"status":41,"city":61,"state":62,"zip":63,"country":64,"countryCode":41,"cosmosGeoPoint":65,"geoPoint":70,"contacts":41},"Sinop University, Türkeli Vocational School (Türkeli MYO)","Türkeli","Sinop","57900","Turkey (Türkiye)",{"type":66,"coordinates":67},"Point",[68,69],34.33861,41.94764,{"lat":69,"lon":68},{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","SEFA HAKTAN HATIK","Assistant Professor","100614033","frequency-dependent-effects-of-auricular-vagus-nerve-stimulation-on-autonomic-and-cardiovascular-parameters-100614033",false,"NCT07274332","Frequency-Dependent Effects of Auricular Vagus Nerve Stimulation on Autonomic and Cardiovascular Parameters","Acute Effects of Different Frequencies of Auricular Vagus Nerve Stimulation on HRV, Blood Pressure, and Respiratory Rate: A Sham-Controlled, Randomized, Crossover Dose-Response Study","AVNS-DRC","Inclusion Criteria:\n\n* 18-30 years\n* Healthy (self-reported)\n* No cardiovascular, neurological, metabolic or psychiatric disorders\n* No regular medication affecting autonomic function\n* Non-smoker\n* BMI 18-29.9\n\nExclusion Criteria:\n\n* Pregnancy\n* Cardiac arrhythmia\n* Hypertension or hypotension\n* Chronic respiratory disorders\n* Active infection\n* Metal implants in cervical area\n* Epilepsy\n* Syncope history\n* Prior vagus stimulation experience",true,"ALL","18 Years","30 Years",{"count":88,"type":89},36,"ESTIMATED","INTERVENTIONAL",[92],"NA","This randomized, sham-controlled, crossover study investigates the acute autonomic effects of transcutaneous cervical vagus nerve stimulation (tcVNS) applied at five different frequencies (0 Hz\u002Fsham, 10 Hz, 25 Hz, 50 Hz, 100 Hz) in healthy adults. The primary objective is to determine how stimulation frequency modulates heart rate variability (HRV), blood pressure, and respiratory rate. The study aims to establish a frequency-specific dose-response model using validated physiological measurements.",[95,96,97,98,99,100],"Vagus Nerve Stimulation","Autonomic Nervous System","Heart Rate","Blood Pressure","Respiration","Healthy Volunteers",[102,103,104,105,106],"Transcutaneous Cervical Vagus Nerve Stimulation","Neuromodulation","Non-invasive Vagus Stimulation","Parasympathetic Activation","Heart Rate Variability","NOT_YET_RECRUITING","2025-11-27",{"date":110,"type":111},"2025-12-10","ACTUAL",{"date":113,"type":89},"2025-12-22",{"date":115,"type":89},"2026-03-15",{"name":73,"class":6},1]