[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of the Basque Country (UPV\u002FEHU)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100631300","lasaion-is-an-evidence-informed-multimodal-self-regulation-program-designed-to-reduce-emotional-distress-and-strengthen-stress-regulation-skills-by-combining-transcutaneous-auricular-vagus-nerve-stimulation-tavns-with-breathing-supported-by-heart-rate-variability-biofeedback-hrv-b-emwave-100631300",false,"NCT07498881","LasaiON is an Evidence-informed, Multimodal Self-regulation Program Designed to Reduce Emotional Distress and Strengthen Stress-regulation Skills by Combining Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) With Breathing Supported by Heart-rate Variability Biofeedback (HRV-B; emWave).","LasaiOn: An Intervention Program to Reduce Emotional Distress","LasaiON","Inclusion Criteria:\n\n* Ability to provide written informed consent\n* Physically healthy, with no relevant uncontrolled medical condition\n* Availability to complete the 5-day study protocol (1 session\u002Fday), including baseline and post-intervention assessments\n* Intact external ear and suitability for electrode placement on the tragus and acquisition of study recordings (EEG, EDA, HRV)\n\nExclusion Criteria:\n\n* History of cardiovascular disease, diabetes, or hypertension\n* Severe bradycardia\n* Active implanted electronic device (e.g., pacemaker, cochlear implant, neurostimulator)\n* History of vagus nerve transection surgery (cervical vagotomy)\n* Pregnancy\n* Current or past clinically significant psychiatric disorder\n* Current or past clinically significant neurological disorder\n* Use of CNS-active medication\n* Substance misuse, including nicotine or alcohol\n* Dermatitis, infection, or lesions of the ear that could interfere with electrode application\n* Ongoing treatment with medications that modulate autonomic nervous system activity or may alter psychophysiological measures (e.g., HRV, EDA, EEG)",true,"ALL",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to evaluate whether the LasaiON program, which combines transcutaneous auricular vagus nerve stimulation (taVNS) with breathing supported by heart rate variability biofeedback (HRV-B; emWave), reduces emotional distress and improves stress-regulation processes in adults. The study will also assess the safety, tolerability, and feasibility of the intervention.\n\nThe main questions it aims to answer are:\n\n1. Does the LasaiON program reduce emotional distress in adults?\n2. What physiological, psychological, and verbal-cognitive changes are observed following the intervention?\n3. What discomforts, adverse effects, or tolerability issues do participants experience during the program?\n\nResearchers will use a prospective 2 × 2 factorial randomized controlled design to examine the effects of stimulation condition (active taVNS vs. sham taVNS) and training condition (active HRV-biofeedback vs. control training), as well as their potential interaction. Participants will be randomly allocated in equal proportions (1:1:1:1) to one of four groups: sham taVNS + control training, sham taVNS + HRV-biofeedback, active taVNS + control training, or active taVNS + HRV-biofeedback.\n\nParticipants will:\n\n* undergo baseline assessments on Day 1 before the intervention;\n* complete 5 consecutive daily 60-minute sessions according to group allocation;\n* undergo post-intervention assessments on Day 5 after the final session;\n* complete psychometric, physiological, and verbal-cognitive assessments, including STAI, HAM-D, WHO-5, EEG, skin conductance, startle response, heart rate variability measures derived using Kubios HRV Premium, and daily five-word reports with valence ratings analyzed using IRaMuTeQ;\n* have adherence and tolerability recorded at each session using a checklist.",[27],"Adult",[29,30],"slow, paced breathing","transauricualr vagus nerve stimulation","NOT_YET_RECRUITING","2026-03-23",{"date":34,"type":35},"2026-03-27","ACTUAL",{"date":37,"type":21},"2026-03-30",{"date":39,"type":21},"2028-03-30",{"name":41,"class":42},"University of the Basque Country (UPV\u002FEHU)","OTHER",""]