[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630073":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":59,"collaborators":63,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Sinop University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active bilateral auricular vagus nerve stimulation","EXPERIMENTAL","Participants receive active bilateral transcutaneous auricular vagus nerve stimulation using an external stimulator. Electrodes are placed on auricular regions targeted for vagal innervation (bilaterally). Stimulation is applied for approximately 10 minutes with standardized parameters and individually adjusted intensity to a clearly perceptible but non-painful level. Spirometry (e.g., FVC, FEV1, PEF) is performed before and after the session; heart rate, heart rate variability, and blood pressure may also be recorded.",[13],"Device: Transcutaneous auricular vagus nerve stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham auricular stimulation (control)","SHAM_COMPARATOR","Participants receive sham stimulation using the same device appearance and session structure. Electrodes are placed on an ear location intended to minimize vagal activation (e.g., ear lobule), and stimulation is delivered at a minimal\u002Flow level to mimic sensation without therapeutic stimulation. The same pre- and post-session spirometry and physiological measurements are collected as in the active arm.",[19],"Device: Sham transcutaneous auricular stimulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Transcutaneous auricular vagus nerve stimulation","Transcutaneous auricular vagus nerve stimulation is delivered bilaterally using an external stimulator with electrodes placed on auricular regions targeted for vagal innervation (e.g., cymba conchae). Stimulation is applied for approximately 10 minutes. Parameters are standardized (e.g., 25 Hz; pulse width 200-300 microseconds), and current intensity is individually adjusted to a clearly perceptible but non-painful level. The procedure is performed in a single visit with pre- and post-intervention spirometry and physiological monitoring as specified in the protocol.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham transcutaneous auricular stimulation","Sham stimulation uses the same device, setup, and session duration to mimic the active procedure. Electrodes are placed on an ear location intended to minimize vagal activation (e.g., ear lobule), and stimulation is delivered at a minimal\u002Flow level to provide a similar sensation without therapeutic vagal stimulation. Pre- and post-session spirometry and other measurements are collected identically to the active arm.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"SEFA HAKTAN HATIK, MSc, PhD","CONTACT","+90 368 271 55 28","4601","haktanhtk@gmail.com",[39],{"facility":40,"status":41,"city":42,"state":26,"zip":43,"country":44,"countryCode":26,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Güzelyurt Neighborhood, Mustafa Bozkurt Street, No: 9, 57900, Türkeli, Sinop, Türkiye","RECRUITING","Sinop","57900","Turkey (Türkiye)",{"type":46,"coordinates":47},"Point",[48,49],35.16253,42.02683,{"lat":49,"lon":48},[52,55,57],{"name":53,"role":54,"phone":26,"phoneExt":26,"email":26},"Uğur BAĞCI, PT, MSc","SUB_INVESTIGATOR",{"name":56,"role":54,"phone":26,"phoneExt":26,"email":26},"Mesut ARSLAN, MSc, PhD",{"name":58,"role":54,"phone":26,"phoneExt":26,"email":26},"Berkay Eren PEHLİVANOĞLU, MSc, PhD",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","SEFA HAKTAN HATIK","Assistant Professor",[64],{"name":5,"class":6},"100630073","transcutaneous-auricular-vagus-nerve-stimulation-and-spirometry-sham-controlled-randomized-trial-100630073",false,"NCT07482930","Transcutaneous Auricular Vagus Nerve Stimulation and Spirometry: Sham-Controlled Randomized Trial","Acute Effects Transcutaneous Auricular Vagus Nerve Stimulation on Spirometric Parameters in Healthy Individuals: A Sham-Controlled Randomized Study","taVNS-SPIRO","Inclusion Criteria:\n\n* Aged 18-40 years.\n* Healthy volunteers.\n* Able to perform spirometry and follow study instructions.\n* Provided written informed consent.\n\nExclusion Criteria:\n\n* Any cardiovascular disease, cardiac arrhythmia, hypertension, or related condition.\n* Any neurological disorder (e.g., diabetes mellitus, peripheral neuropathy, epilepsy).\n* Any diagnosed psychiatric disorder.\n* Any respiratory disease (e.g., asthma, chronic obstructive pulmonary disease).\n* Pregnancy or suspected pregnancy.\n* Ear conditions that prevent stimulation (infection, open wound, pain\u002Ftenderness) or presence of a piercing at\u002Fnear the stimulation site.\n* Vigorous exercise within 24 hours prior to measurement.\n* Caffeine intake, smoking, or alcohol consumption within 4-6 hours prior to measurement.\n* Marked intolerance or hypersensitivity to the device or the procedure.\n* Inability to follow instructions during measurements or refusal to complete the session.",true,"ALL","18 Years","40 Years",{"count":78,"type":79},50,"ESTIMATED","INTERVENTIONAL",[82],"NA","This study will examine the short-term effects of transcutaneous auricular vagus nerve stimulation (a non-invasive electrical stimulation delivered through the outer ear) on lung function measured by spirometry in healthy adults. The vagus nerve is involved in many automatic body functions, and ear-based stimulation has been used in research to explore its possible effects on different physiological systems. However, it is not clear whether a brief stimulation session can acutely influence breathing test results in people without respiratory disease.\n\nHealthy volunteers aged 18-40 will take part in one laboratory visit. Participants will be randomly assigned to one of two groups: (1) active bilateral stimulation applied to specific ear regions that are known to be innervated by the vagus nerve, or (2) sham stimulation using the same device setup but designed to minimize vagal activation. The stimulation session will last approximately 10 minutes. Before and after the stimulation, participants will perform standard spirometry (breathing) tests. Primary spirometric outcomes will include common measures of lung function such as forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and peak expiratory flow (PEF). Heart rate, heart rate variability, and blood pressure may also be recorded to monitor physiological responses and safety during the visit.\n\nParticipation is voluntary and participants may withdraw at any time. The procedure is considered minimal risk. Possible side effects are usually mild and temporary, such as tingling, warmth, or mild discomfort at the ear. Rarely, participants may feel lightheaded; if this occurs, the procedure will be stopped and the participant will be monitored until symptoms resolve. There is no guaranteed direct benefit to participants. The results may help clarify whether short-term ear-based vagus nerve stimulation can influence spirometric parameters and may inform future studies on autonomic and respiratory interactions.",[85,86,87,88,89],"Vagus Nerve Stimulations","Spirometry","Autonomic Nervous System (ANS) Functioning and Mood State","Blood Pressure Monitoring","Respiratory Function Tests",[91,92,93,94,95,96],"transcutaneous auricular vagus nerve stimulation","spirometry","autonomic nervous system","sham stimulation","pulmonary function test","blood pressure","2026-03-16",{"date":99,"type":100},"2026-03-19","ACTUAL",{"date":102,"type":100},"2026-03-17",{"date":104,"type":79},"2026-04-25",{"name":61,"class":6},1]