[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643838":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":55,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Academisch Ziekenhuis Maastricht","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcutaneous Auricular Vagal Nerve Stimulation","ACTIVE_COMPARATOR","Transcutaneous auricular vagal nerve stimulation, for 30 minutes",[13],"Device: Vagal Nerve Stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham stimulation","PLACEBO_COMPARATOR","Sham stimulation with a non-conducting electrode, for 30 minutes",[19],"Device: Sham stimulation",[21,26],{"type":22,"name":23,"description":9,"armGroupLabels":24,"otherNames":25},"DEVICE","Vagal Nerve Stimulation",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Sham stimulation with a non-conducting electrode",[15],[30],{"name":31,"affiliation":32,"role":33},"Daniel Keszthelyi, MD, PhD","Maastricht University Medical Center","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Fleur Veldman, MD","CONTACT","+31433884051","fleur.veldman@maastrichtuniversity.nl",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":25},"Maastricht University","RECRUITING","Maastricht","Limburg","6229ER","Netherlands","NL",{"type":50,"coordinates":51},"Point",[52,53],5.68889,50.84833,{"lat":53,"lon":52},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Daniel Keszthelyi","Prof. Dr. Keszthelyi","100643838","exploring-the-role-of-tavns-in-nausea-management-100643838",false,"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.",true,"ALL","18 Years","65 Years",{"count":71,"type":72},35,"ESTIMATED","INTERVENTIONAL",[75],"NA","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.",[78],"Healthy Adult Participants",[23,80,81],"Nausea","Randomised Controlled Trial","2026-06-02",{"date":84,"type":85},"2026-06-08","ACTUAL",{"date":87,"type":85},"2025-12-08",{"date":89,"type":72},"2026-09",{"name":57,"class":6},1]