[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529197":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":73,"collaborators":25,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":25,"enrollmentInfo":85,"targetDuration":25,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":51,"whyStopped":25,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Saint Etienne","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with active tVNS","EXPERIMENTAL","Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid will be included.",[13,14],"Other: APA program","Other: Active transcutaneous VNS",{"label":16,"type":17,"description":11,"interventionNames":18},"Patients with sham tVNS","SHAM_COMPARATOR",[13,19],"Other: Sham transcutaneous VNS",[21,26,30],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"APA program","An APA program of 12 weeks, 2 sessions of 1h\u002Fweek for mixed endurance, strengthening and stretching work. The program can be realized at home or in structure.",[9,16],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Active transcutaneous VNS","After each APA session, a 1h-tVNS session is delivered on the conchae aurea of the left ear, in resting condition. Parameters of tVNS : frequency 20Hz, impulsion 200ms, amplitude 1mA below the unpleasant sensation level.",[9],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":25},"Sham transcutaneous VNS","After each APA session, a 1h-tVNS session is delivered on the left earlobe, in resting condition. Parameters of tVNS : frequency 20Hz, impulsion 200ms, amplitude 1mA below the unpleasant sensation level.",[16],[35],{"name":36,"affiliation":5,"role":37},"David HUPIN, MD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","(0)4 77 82 84 13","+33","david.hupin@chu-st-etienne.fr",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Hélène RAINGARD, CRA","(0)4 77 12 08 26","helene.raingard@chu-st-etienne.fr",[49],{"facility":50,"status":51,"city":52,"state":25,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Centre Hospitalier de Saint-Etienne","RECRUITING","Saint-Etienne","42055","France","FR",{"type":57,"coordinates":58},"Point",[59,60],4.39,45.43389,{"lat":60,"lon":59},[63,64,66,67,70,71],{"name":36,"role":40,"phone":25,"phoneExt":42,"email":25},{"name":65,"role":40,"phone":25,"phoneExt":25,"email":25},"Frédéric ROCHE, MD PhD",{"name":36,"role":37,"phone":25,"phoneExt":25,"email":25},{"name":68,"role":69,"phone":25,"phoneExt":25,"email":25},"Léonard FEASSON, MD PhD","SUB_INVESTIGATOR",{"name":65,"role":69,"phone":25,"phoneExt":25,"email":25},{"name":72,"role":69,"phone":25,"phoneExt":25,"email":25},"Philippe BOIRON, MD",{"type":74,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100529197","transcutaneous-vagus-nerve-stimulation-as-a-complementary-therapy-to-exercise-in-chronic-fatigue-100529197",false,"NCT06170645","Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue","Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue: Single-center, Controlled, Randomized, Blinded Study","PAF-tVNS","Inclusion Criteria:\n\n* Patient over 18 years old\n* Signature of informed consent\n* Confirmed diagnosis of fibromyalgia or long Covid (ACR 2016 criteria and persistent symptoms lasting more than 6 months after a positive RT-PCR test, respectively)\n* Persistent fatigue after an exercise rehabilitation program (FSS score \\> 36)\n* Physical inactivity, i.e. \\\u003C150 minutes per week of physical activity\n\nExclusion Criteria:\n\n* Pre-existing atrial fibrillation,\n* Left ventricular ejection fraction \\\u003C40%\n* Severe heart failure\n* Recent stroke or myocardial infarction (\\\u003C6 months)\n* Unilateral or bilateral vagotomy\n* Pregnancy or breastfeeding","ALL","18 Years",{"count":86,"type":87},60,"ESTIMATED","INTERVENTIONAL",[90],"NA","Chronic fatigue is enhanced by adapted physical activity (APA) programs. Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid benefit from a 4-6 week APA program, with 2 sessions per week. While most patients are improved by these exercise-training programs, for some the benefits remain very modest, and patients describe persistent fatigue. The literature unanimously describes the necessity of longer APA protocols (8-12 weeks, 2-3 sessions\u002Fweek) for fatigue reduction in fibromyalgia and long Covid. However, it seems difficult to adhere to an optimal program as described in the literature for these fatigued patients. The investigators want to test a device that would both reduce fatigue and improve recovery between APA sessions, in order to gradually reach the recommendations for APA practice. Transcutaneous vagal nerve stimulation (tVNS) seems to be a promising approach. Thus, combining an APA intervention with a tVNS protocol could potentiate the expected and now well-known effect of exercise.",[93],"Chronic Fatigue Syndrome",[95,96,97],"Chronic fatigue","Transcutaneous vagal nerve stimulation (tVNS)","adapted physical activity (APA)","2026-05-05",{"date":100,"type":101},"2026-05-06","ACTUAL",{"date":103,"type":101},"2024-10-03",{"date":105,"type":87},"2028-08",{"name":5,"class":6},1]