[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Daniel Keszthelyi\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100643592","the-effect-of-tavns-and-upper-gi-motility-100643592",false,"NCT07632378","The Effect of taVNS and Upper GI Motility","The Effect of Non-invasive Transauricular Vagus Nerve Stimulation on Upper Gastrointestinal Motility in Healthy Individuals","Inclusion Criteria:\n\n* Healthy participants (defined as those without a pre-existing medical comorbidity, including those without a history of cardiac arrhythmia).\n* Age between 18 and 55 years.\n* Ability to understand and speak the Dutch language.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Use of any substances (such as medication or recreational drugs) influencing gastrointestinal motility\n* Not meeting the inclusion criteria above.\n* Students and employees of Maastricht University are not precluded from participation, unless they have a direct personal, professional of hierarchical position with regards to any of the study team members or their department.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},12,"ESTIMATED","INTERVENTIONAL",[25],"NA","This single-center randomized controlled cross-over trial aims to investigate the effect of transcutaneous auricular vagus nerve stimulation on upper gastrointestinal motility in healthy individuals.\n\nThe primary aim of this study is to assess the impact of tVNS on gut motor function, with regards to its potential to induce phase III contractions in the upper GI tract.\n\nSecondary objectives include:\n\n* To study the effect of tVNS on other parameters characterizing upper GI motility such as the number of duodenal phase III contractions, gastric and duodenal phase MMCs, amplitude of antral contractions and motility index\n* To study the effect of tVNS on plasma levels of motilin and PP\n* To evaluate the effect of tVNS on parameters related to autonomic outflow, using a Shimmer3 GSR Sensor for heart rate variability and skin conductance.\n* To compare the results of the measurements of antroduodenal manometry with measurements of Gastric Alimetry\n\nParticipants will undergo tVNS (applied to the cymba conchae of the left ear) alternating with sham stimulation (using a non-conducting electrode) in a blinded, pre-randomized fashion, using two 4-hour blocks during an 8-hour fasted antroduodenal manometry recording period. Optionally, participants may simultaneously also undergo body surface gastric mapping using the Gastric Alimetry system.",[28],"Healthy Adult Participants",[30,31,32,33,34],"Vagal Nerve Stimulation","Upper GI motility","Randomised Controlled Trial","Antroduodenal Manometry","Gastric Alimetry","RECRUITING","2026-06-02",{"date":38,"type":39},"2026-06-08","ACTUAL",{"date":41,"type":39},"2025-02-25",{"date":43,"type":22},"2026-06",{"name":45,"class":46},"Daniel Keszthelyi","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":47},"100643838","exploring-the-role-of-tavns-in-nausea-management-100643838","NCT07632456","Exploring the Role of taVNS in Nausea Management","Exploring the Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Alleviating Nausea in Healthy Adults: a Double-blind Randomized Controlled Trial","Inclusion Criteria:\n\n* Healthy participants (defined as those without a pre-existing medical comorbidity).\n* Aged between 18-65 years.\n* Ability to understand and speak the Dutch language.\n* BMI between 18 and 25 kg\u002Fm2\n\nExclusion Criteria:\n\n* Medical history of chronic or severe diseases affecting the cardiovascular, respiratory, urogenital, gastrointestinal\u002Fhepatic, haematologic\u002Fimmunologic, HEENT (head, ears, eyes, nose, throat), dermatological\u002Fconnective tissue, musculoskeletal, metabolic\u002Fnutritional, endocrine, neurological\u002Fpsychiatric systems.\n* A history of major abdominal surgery.\n* Gastrointestinal complaints.\n* Any use of medication, especially those affecting gastric motility and nausea, apart from oral contraceptives.\n* Current or lifetime psychopathology (including PHQ-9 and GAD-7 scores \\> 10)\n* Substance abuse, including excessive alcohol consumption (\\>20 alcoholic consumptions per week) and the use of recreational drugs.\n* Smoking.\n* Pregnancy, lactation, or intention to become pregnant during the study period\n* Use of devices (e.g., cochlear implants) or other conditions (e.g. wounds, permanent ear-piercing) complicating the use of the tVNS device.\n* Administration of investigational drugs or participation in any scientific intervention study that might interfere with this study (to be determined by the principal investigator) within 180 days preceding the commencement of the study.\n* Students and employees of Maastricht University are not precluded from participation, unless they have a direct personal, professional or hierarchical position with regards to any of the study team members or their department.","65 Years",{"count":57,"type":22},35,[25],"This single-center randomized controlled trial aims to investigate the efficacy of transcutaneous auricular vagus nerve stimulation in alleviating nausea in healthy adults.\n\nThe primary aim of this study is to assess the efficacy of taVNS in reducing nausea in healthy adults subjected to nausea induction through intragastric lipid infusion, compared to sham stimulation, as measured by 0-100 Visual Analogue Scale (VAS) scores.\n\nThe secondary objectives include evaluating the potential of taVNS to alleviate other gastrointestinal symptoms, such as abdominal pain, bloating, and fullness, as well as exploring its effects on the desire to eat, all measured using 0-100 VAS scores. Additionally, changes in autonomic parameters, plasma levels of ghrelin and motilin, and salivary cortisol will be evaluated. The relationship between the nausea response and affective symptoms, as well as personality traits, will also be explored.\n\nParticipants will be randomly assigned to either the taVNS or the sham stimulation group, with the intervention administered for 30 minutes immediately following nausea induction through intragastric lipid infusion.",[28],[30,62,32],"Nausea",{"date":38,"type":39},{"date":65,"type":39},"2025-12-08",{"date":67,"type":22},"2026-09",{"name":45,"class":46},""]