[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555353":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":43,"locations":52,"responsibleParty":66,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":26,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":92,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University Hospital Tuebingen","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Monitoring with high\u002Flow-intensity stimulation","EXPERIMENTAL","The cross-over design includes one group which starts with high-intensity stimulation (n = 40) and another group, who starts with low-intensity stimulation (n = 40). The first group receives at first high-intensity for 6 weeks, followed by a low-intensity stimulation phase for 6 weeks. To control for placebo effects, other forty individuals start with the 6-week low-intensity stimulation phase followed by 6 weeks of high-intensity tVNS stimulation phase.",[13,14,15],"Device: transcutaneous vagus nerve stimulation","Behavioral: Monitoring","Device: cardiowatch bracelet",{"label":17,"type":10,"description":18,"interventionNames":19},"Monitoring without stimulation","Another group of patients is included as a control group (n = 40) undergoing 'treatment as usual' for Long\u002FPost Covid. This group of participants receive the same monitoring throughout their participation during 12 weeks as the Stimulation-Group. As there is no standardized treatment protocol for Long\u002FPost Covid, 'treatment as usual' implies a supportive approach.\n\nThis group of participants have the option to receive taVNS stimulation after participating in the study.",[14,15],[21,27,32],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","transcutaneous vagus nerve stimulation","The study employs a CE-certified tVNS® E device, ensuring European safety standards (EU regulation 2017\u002F745 on medical devices). This device features a stimulation cycle of 28 seconds on and 32 seconds off, with a 25 Hz impulse frequency. For the high-intensity group, the stimulation intensity will be individually adjusted in the session before starting the high-intensity tVNS stimulation at home. Recommended daily usage is max. 4 hours, after which it automatically shuts off.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BEHAVIORAL","Monitoring","Participants are monitored over 12 weeks using a combination of questionnaires and ecological momentary assessment. This approach allows for a comprehensive assessment of the patient's health and well-being.",[9,17],{"type":22,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"cardiowatch bracelet","The study employs the medically certified cardiowatch bracelet from Corsano (CE-MDR medical certification, FDA 510 (k) cleared) for continuous monitoring of vital signals, such as heart rate, heart rate variability, breathing rate, SpO2, physical activity and sleep.",[9,17],[37,41],{"name":38,"affiliation":39,"role":40},"Nils B. Kroemer, Prof. Dr.","Department of Psychiatry & Psychotherapy, University of Tübingen,Tübingen, 72076","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":39,"role":40},"Andreas J. Fallgatter, Prof. Dr.",[44,48],{"name":38,"role":45,"phone":46,"phoneExt":26,"email":47},"CONTACT","+4922828711151","nils.kroemer@uni-tuebingen.de",{"name":49,"role":45,"phone":50,"phoneExt":26,"email":51},"Andreas Stengel, Prof. Dr.","+497071 29-86714","andreas.stengel@med.uni-tuebingen.de",[53],{"facility":54,"status":26,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":26},"Department of Psychiatry & Psychotherapy, University of Tübingen","Tübingen","Baden-Wurttemberg","72076","Germany","DE",{"type":61,"coordinates":62},"Point",[63,64],9.05222,48.52266,{"lat":64,"lon":63},{"type":67,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100555353","transcutaneous-vagus-nerve-stimulation-tvns-for-improved-recovery-after-exertion-100555353",false,"NCT06510985","Transcutaneous Vagus Nerve Stimulation (tVNS) for Improved Recovery After Exertion.","Transcutaneous Vagus Nerve Stimulation (tVNS) for Improved Recovery After Exertion in Patients With Long\u002FPost-COVID.","Inclusion Criteria:\n\n* individuals who have previously tested positive for SARS-CoV-2 infection (preferred PCR-Test) or have a medically confirmed history of COVID-19 (preferred SARS-CoV-2 Antibody-test) and have persistent symptoms (including Post-COVID) .\n* clinical diagnoses made by physician: individuals are included with at least one persistent symptom for at least 4 weeks (Long-COVID) or at least 8 weeks (Post-COVID) following the SARS-CoV-2 infections, such as fatigue, shortness of breath, brain fog, headaches, irritability, cognitive difficulties, muscle or joint pain, sleep disturbances, etc.\n* Participants should not have an alternative explanation for their persistent symptoms, ruling out other medical or psychiatric conditions.\n\nExclusion Criteria:\n\n* lack of capacity for consent\n* insufficient German language skills: Participants must have sufficient (B2 German) language skills to understand the informed consent form, study procedures, and questionnaires.\n* Intensive Care Unit treatment during COVID-19 infection\n* BMI \\> 18.5 \\& BMI \\\u003C 35 kg\u002Fm2\n\nLifetime (according to DSM 5):\n\n* brain injury, stroke, epilepsy, or history of seizures\n* schizophrenia\n* bipolar disorder\n* severe substance use disorders, except tobacco\n* cardiac arrhythmia, coronary heart disease\n* 12-month prevalence: pregnancy or nursing\n\nAdditional exclusion criteria for a safe application of tVNS:\n\n* active implant (pacemaker, cochlear implant, implanted electrode device) and cerebral shunts\n* required permanent use of left-sided hearing aid\n* ear infections, open wounds, or impaired skin at electrode sites","ALL","18 Years","65 Years",{"count":79,"type":80},120,"ESTIMATED","INTERVENTIONAL",[83],"NA","Widespread infection with SARS-CoV-2 has resulted in millions of people having Post-COVID. Post-COVID is a complex, non-monolithic disease with diverse clinical manifestations. Symptoms range from fatigue, brain fog, muscle aches and shortness of breath, affecting multiple organ systems simultaneously. To directly address this multi-organ component of Post-COVID, innovative treatment methods are urgently needed. One potential treatment that we will investigate in our study, is the intervention via the vagus nerve, as the cranial nerve plays a central role in communication between the body and the brain and influences targeted behavior. This innovative approach is based on our clinically relevant findings regarding the effects where acute tVNS increased the level of effort (Neuser et al., 2020; Ferstl et al., 2021), specifically targeting a key symptom of Post-COVID. In the proposed study, the investigators aim to investigate the effectiveness of transcutaneous vagus nerve stimulation (tVNS) as a non-invasive, self-administered treatment for Post-COVID symptoms at home. To evaluate the clinically relevant effects of repeated taVNS application (high-intensity stimulation), the investigators will employ a randomized cross-over design to investigate stimulation-induced changes in fatigue, depression and motivation to work for reward compared to low-intensity stimulation and to a control group.",[86],"Post-COVID-19 Syndrome",[86,88,89,90,91],"taVNS","effort","fatigue","heart rate","NOT_YET_RECRUITING","2024-07-18",{"date":95,"type":96},"2024-07-19","ACTUAL",{"date":95,"type":80},{"date":99,"type":80},"2027-12",{"name":5,"class":6},1]