[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568550":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":37,"locations":43,"responsibleParty":64,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":23,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":23,"enrollmentInfo":79,"targetDuration":23,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":46,"whyStopped":23,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University Hospital Tuebingen","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"High-low tVNS","EXPERIMENTAL","Participants in this group will be instructed to use the tVNS device every day for the first six weeks according to the manufacturer's guidelines, at an intensity where they can feel a tingling sensation but below the pain threshold. After six weeks (T2) of intervention, they will be asked to switch to a different protocol for the next six weeks, using the device at the lowest possible intensity. Additional instructions will be provided, and they will be informed that this stimulation uses different parameters set by the research team.",[13],"Device: transcutaneous vagus nerve stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Low-high tVNS","ACTIVE_COMPARATOR","Participants in this group will receive the inverted intervention, with the first six weeks of stimulation at the lowest possible intensity (0.1 mA) with the same instructions regarding duration of stimulations, followed by six weeks of high-intensity stimulation as instructed by the manufacturer.",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"No tVNS","NO_INTERVENTION","This group of participants will be included in all measurements (T1-T3) and check-ups, except for the tVNS stimulation.",null,[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"DEVICE","transcutaneous vagus nerve stimulation","Two groups will use a tVNS stimulator for 12 weeks. Group 1 will apply active stimulation for up to 4 hours daily at a comfortable level for 6 weeks, while Group 2 will use it at the lowest intensity (0.1 mA). After 6 weeks (T2), the groups will switch. Participants will be instructed to use the device for at least 1 hour a day, with a recommendation of 4 hours, following guidelines and recent studies. The CE-certified tVNS® E device non-invasively stimulates the vagus nerve via the ear. It is approved for treating a.o.depression. Device parameters (intensity, pulse length, frequency) mimic invasive VNS techniques, ensuring safe and effective signal transmission. Stimulation will be applied to the left ear, with intensity adjusted to a tingling sensation, avoiding discomfort. The study follows an approved protocol, with low-intensity stimulation as a control. The device delivers biphasic impulses at 25 Hz, with 28 seconds ON and 32 seconds OFF, and is safe for extended use.",[9,15],[31,35],{"name":32,"affiliation":33,"role":34},"Birgit Derntl, Prof., PhD","University Hospital Tübingen","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":33,"role":34},"Nils Kroemer, Prof., Dr. rer. nat.",[38],{"name":39,"role":40,"phone":41,"phoneExt":23,"email":42},"Julia Siodmiak, M.sc.","CONTACT","+49 (0)7071 29-85736","julia.siodmiak@med.uni-tuebingen.de",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"University Hospital Tuebingen; Department of Psychiatry and Psychotherapy","RECRUITING","Tübingen","Baden-Wurttemberg","72076","Germany","DE",{"type":53,"coordinates":54},"Point",[55,56],9.05222,48.52266,{"lat":56,"lon":55},[59,61,63],{"name":39,"role":40,"phone":60,"phoneExt":23,"email":42},"+49 07071 29-86119",{"name":62,"role":40,"phone":23,"phoneExt":23,"email":23},"Birgit Derntl, Prof., PhD, M.sc.",{"name":39,"role":40,"phone":23,"phoneExt":23,"email":23},{"type":65,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[67],{"name":68,"class":6},"German Center for Mental Health","100568550","investigation-of-tvns-administration-on-postpartum-mental-health-100568550",false,"NCT06682689","Investigation of TVNS Administration on Postpartum Mental Health","Integrative Investigation of Transcutaneous Vagus Nerve Stimulation: Impact on Postpartum Mental Health Through Wearable Technology, Hormonal Analysis and Modulatory Factors","Inclusion Criteria:\n\n* No malformation of fetal organs (no abnormalities detected during \"organ screening\").\n* Ability to provide written consent for themselves.\n* Sufficient German language skills to communicate and understand study procedures.\n\nExclusion Criteria:\n\n* Exclusion criteria for tVNS use (i.e., pregnancy, active implants such as cochlear implants or cardiac pacemakers, cerebral shunts, skin problems, cardiovascular health issues).\n* Cardiac arrhythmias or coronary heart disease.\n* Neurological disorders.\n* Current diagnosis or episode of a mood disorder.\n* Diagnosed schizophrenia spectrum and other psychotic disorders.\n* Severe substance use disorders.\n* Individual exclusion may also occur based on other health issues if the study clinician determines that participation in the study may pose a disadvantage for the participant or the child.",true,"FEMALE","18 Years",{"count":80,"type":81},120,"ESTIMATED","INTERVENTIONAL",[84],"NA","The aim of the study is to explore whether transcutaneous vagus nerve stimulation (tVNS) may be effective in preventing mood swings and depressive symptoms in the postpartum phase, as well as serving as a supplementary intervention in cases where mood symptoms develop. The study will investigate the effects of tVNS intervention during the first 12 weeks postpartum. Pregnant women will be recruited for the study, and the intervention will begin shortly after giving birth. Participants will receive different instructions on how to use the tVNS device. Additional parameters such as physiological functions, chronic stress, hormones, environment, and personality traits will also be assessed.",[87,88,89,90],"Postpartum Depression (PPD)","Postpartum Anxiety","Postpartum Sadness","Postpartum Blues",[92,93,94,95,96],"tVNS","Transcutaneous vagus nerve stimulation","Postpartum","PPD","Depression","2024-11-08",{"date":99,"type":100},"2024-11-12","ACTUAL",{"date":102,"type":81},"2024-11",{"date":104,"type":81},"2026-12",{"name":5,"class":6},1]