[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561975":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":50,"studyPopulation":41,"armGroups":51,"interventions":64,"overallOfficials":74,"centralContacts":79,"locations":85,"responsibleParty":105,"collaborators":41,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":115,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":41,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":88,"whyStopped":41,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Indiana University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":31,"otherOutcomes":41},[9,13,16,19,22,25,28],{"measure":10,"description":11,"timeFrame":12},"Change in plasma insulin levels","Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active\u002Fcontrol group on plasma insulin levels.","Study Days 1 and 2",{"measure":14,"description":15,"timeFrame":12},"Change in C-peptide levels","Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active\u002Fcontrol group on C-peptide levels.",{"measure":17,"description":18,"timeFrame":12},"Change in glucose levels","Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active\u002Fcontrol group on glucose levels",{"measure":20,"description":21,"timeFrame":12},"Change in heart rate variability","Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active\u002Fcontrol group on heart rate variability.",{"measure":23,"description":24,"timeFrame":12},"Association between changes in heart rate variability and plasma insulin levels","Pearson's correlation coefficients will be used to evaluate the association between change in heart rate variability (end of stimulation minus baseline) with changes in plasma insulin levels (end of stimulation minus baseline). Heart rate variability will be used as an indication of changes in parasympathetic or sympathetic activation.",{"measure":26,"description":27,"timeFrame":12},"Association between changes in heart rate variability and C-peptide levels","Pearson's correlation coefficients will be used to evaluate the association between change in heart rate variability (end of stimulation minus baseline) with changes in C-peptide levels (end of stimulation minus baseline). Heart rate variability will be used as an indication of changes in parasympathetic or sympathetic activation.",{"measure":29,"description":30,"timeFrame":12},"Association between changes in heart rate variability and glucose levels","Pearson's correlation coefficients will be used to evaluate the association between change in heart rate variability (end of stimulation minus baseline) with changes in glucose levels (end of stimulation minus baseline). Heart rate variability will be used as an indication of changes in parasympathetic or sympathetic activation.",[32,35,38],{"measure":33,"description":34,"timeFrame":12},"Correlation between gender and changes in circulating plasma insulin levels","Pearson's correlation coefficient will be calculated for the association between change in circulating plasma insulin levels (end of stimulation minus baseline) and patient gender.",{"measure":36,"description":37,"timeFrame":12},"Correlation between age and changes in circulating plasma insulin levels","Pearson's correlation coefficient will be calculated for the association between change in circulating plasma insulin levels (end of stimulation minus baseline) and patient age.",{"measure":39,"description":40,"timeFrame":12},"Correlation between body mass index and changes in circulating plasma insulin levels","Pearson's correlation coefficient will be calculated for the association between change in circulating plasma insulin levels (end of stimulation minus baseline) and patient body mass index.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":6,"observationalModel":41,"timePerspective":41,"maskingInfo":45},"RANDOMIZED","PARALLEL",{"masking":46,"maskingDescription":47,"whoMasked":48},"SINGLE","Individuals will be either assigned to either the Active or the Sham groupings. Both groups will have the device placed at Visit 1, but only the active group will receive stimulation. Participants are blinded to which group they are in.",[49],"PARTICIPANT","Healthy volunteer subjects will be recruited for this project, which will be completed at a up to 2 study visits.\n\nPrior to each visit, participants will be asked not to eat or drink anything (except a small amount of water to take medications) for 8-10 hours.\n\nWhen participants arrive to Study Visit 1, they will be asked to lie in a supine position and will be fitted with:\n\n* ECG electrodes, placed on the chest, arms\u002Flegs for electrocardiogram (ECG) recordings and behind each ear and just below the jaw on each side to record vagal nerve activity\n* a butterfly needle catether for blood sample collections.\n\nAfter the ECG electrodes are placed and the butterfly needle catheter is inserted, the first of 4 blood samples will be collected. The TENS unit clip will then be placed (after cleaning the left ear with an alcohol wipe) and a 20 minute baseline recording will be made, followed by the collection of a second blood sample.\n\nParticipants will then undergo their randomly assigned experimental condition (either active stimulation delivered via the TENS device, or no stimulation) for 40 minutes. At the end of the experimental period, a third blood sample is collected and the TENS device is turned off (for participants in the active stimulation group). Participants will then continue to lie on their back for an additional 20 minutes of recovery, after which the fourth and final blood sample is collected. The TENS clip is then removed and the study visit is complete.\n\nContinuous vagal nerve and ECG recordings are obtained during the baseline, experimental, and recovery periods.\n\nParticipants will be asked if they wish to return for a second study visit, at which no TENS clip will be placed but the remaining Visit 1 procedures will be repeated.",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"Active Stimulation, then No electrodes","EXPERIMENTAL","After an initial baseline blood sample is drawn, a TENS unit electrode clip will be placed on the inside of the outer ear and vagal nerve recordings are initiated. After 20 minutes of baseline recording, a second blood sample is drawn, after which, the TENS unit is turned ON for 40 minutes of stimulation. At the end of the stimulation period, a third blood sample is drawn and the TENS device is then turned OFF. After 20 minutes of recovery, a fourth and final sample of blood is drawn. Vagal nerve activity recordings are continued until the final blood sample is drawn.\n\nSubjects will be asked to return for an additional visit during which the TENS unit will not be placed, but the same vagal nerve recordings and blood draws will be obtained.",[57],"Device: Transcutaneous Auricular Vagus Nerve Stimulation",{"label":59,"type":60,"description":61,"interventionNames":62},"Sham Stimulation, then No Electrodes","SHAM_COMPARATOR","After an initial baseline blood sample is drawn, a TENS unit electrode clip will be placed on the inside of the outer ear, but will not be turned on. Vagal nerve recordings will be initiated. After 20, 60 and 80 minutes, additional blood samples are drawn. Vagal nerve activity recordings are continued until the final blood sample is drawn.\n\nSubjects will be asked to return for an additional visit during which the TENS unit will not be placed, but the same vagal nerve recordings and blood draws will be obtained.",[63],"Device: Sham Procedure (No Stimulation)",[65,70],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":41},"DEVICE","Transcutaneous Auricular Vagus Nerve Stimulation","For participants in the active stimulation group, electrical stimuli are delivered continuously for 40 minutes at a pulse width of 300 microseconds, pulse frequency of 25 Hz, and pulse amplitude of 0.5 to 1.5 mA based on the tolerance of the patient. Stimuli current and frequency may be decreased, if necessary, to minimize participant discomfort.",[53],{"type":66,"name":71,"description":72,"armGroupLabels":73,"otherNames":41},"Sham Procedure (No Stimulation)","The TENS device will be placed but not turned on.",[59],[75],{"name":76,"affiliation":77,"role":78},"Thomas V Nowak, MD","IU Medical Scool","PRINCIPAL_INVESTIGATOR",[80],{"name":81,"role":82,"phone":83,"phoneExt":41,"email":84},"Maureen Schilling, BS","CONTACT","3172782064","maschi@iu.edu",[86],{"facility":87,"status":88,"city":89,"state":90,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"Indiana University Hospital","RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":95,"coordinates":96},"Point",[97,98],-86.15804,39.76838,{"lat":98,"lon":97},[101,102],{"name":81,"role":82,"phone":83,"phoneExt":41,"email":84},{"name":76,"role":82,"phone":103,"phoneExt":41,"email":104},"3179484272","tvnowak@iu.edu",{"type":78,"investigatorFullName":106,"investigatorTitle":107,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Thomas V. Nowak","Principal Investigator","100561975","effect-of-transcutaneous-auricular-vagus-nerve-stimulation-tavns-on-plasma-insulin-levels-100561975",false,"NCT06597149","Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Plasma Insulin Levels","TaVNS","Inclusion Criteria:\n\n* Healthy Volunteers\n* Aged 18-70\n* Willing to have ECG electrodes placed on their neck and chest areas.\n* Willing to have electrodes placed in the external ear.\n* Willing to have an indwelling catheter placed to avoid multiple sticks for blood draw.\n\nExclusion Criteria:\n\n* Unable to provide consent.\n* Diabetes diagnosis per patient report\n* Having known allergies to adhesive on electrode pads or bandages\n* Having gastric motility issues as determined by the PI or clinical coordinator.\n* Taking any medications that may affect gastric motility or cardiac variability, i.e. alpha or beta blockers for hypertension.\n* Pregnant females\n* Those unwilling to have the taVNS device placed in their ear.\n* Those unwilling to consent to a blood draw.\n* Prisoners",true,"ALL","18 Years","70 Years",{"count":120,"type":121},60,"ESTIMATED","INTERVENTIONAL",[124],"NA","The vagus or vagal nerve is a nerve that sends signals from the brain to other parts of the body to control involuntary functionm, including stomach function, and it is important to the regulation of insulin, C-peptide, and glucose levels. The purpose of this study is to evaluate whether electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve and influence the levels of insulin, C-peptide, and glucose. If it does, investigators hope that this will help innovate treatment of patients with nausea, vomiting, and disordered stomach function, and patients with diabetes.",[127],"Healthy",[127,129],"Individual","2026-09-28",{"date":132,"type":133},"2026-10-01","ACTUAL",{"date":135,"type":133},"2025-04-21",{"date":137,"type":121},"2027-05-31",{"name":5,"class":6},1]