[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631300":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":34,"locations":40,"responsibleParty":60,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":30,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":33,"maxAge":33,"enrollmentInfo":77,"targetDuration":33,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":89,"whyStopped":33,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of the Basque Country (UPV\u002FEHU)","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Sham taVNS + HRV-Biofeedback Training","EXPERIMENTAL","Participants assigned to this arm will receive sham taVNS together with active HRV-biofeedback training over 5 consecutive intervention days, with one supervised 60-minute session per day. In each session, participants will sit comfortably in front of a computer. A sham taVNS device will be positioned at the tragus but will not deliver active electrical stimulation, while heart rate variability biofeedback will be provided through an ear sensor connected to the emWave platform. Sessions will include a brief pre-session checklist, fitting of psychophysiological recording equipment (EEG, HRV, EDA\u002FEMG), a short quiet baseline, approximately 10 minutes of slow paced breathing (\\~6 breaths\u002Fmin) supported by Coherence Coach, followed by post-session tolerability\u002Fcomfort ratings. This arm is designed to isolate the effect of active HRV-biofeedback training in the absence of active taVNS.",[13],"Combination Product: LasaiON",{"label":15,"type":10,"description":16,"interventionNames":17},"Active taVNS + Control Training","Participants assigned to this arm will receive active transcutaneous auricular vagus nerve stimulation (taVNS) combined with control training across five consecutive intervention days, with one supervised 60-minute session per day. During each session, participants will be seated comfortably in front of a computer. Active taVNS will be delivered at the tragus, while the training component will consist of a control condition without the Coherence Coach application, rather than active HRV biofeedback. Sessions will include a brief pre-session checklist, fitting of psychophysiological recording equipment (EEG, HRV, and EDA\u002FEMG), a short resting baseline, and post-session ratings of tolerability and comfort. This arm is intended to isolate the effect of active taVNS in the absence of active HRV biofeedback training.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Active taVNS + HRV-Biofeedback Training","Participants assigned to this arm will receive the full active LasaiON intervention over 5 consecutive intervention days, with one supervised 60-minute session per day. In each session, participants will sit comfortably in front of a computer while receiving active transcutaneous auricular vagus nerve stimulation (taVNS) at the tragus together with active heart rate variability biofeedback (HRV-biofeedback) breathing training supported by the emWave platform. Sessions will include a brief pre-session checklist, fitting of psychophysiological recording equipment (EEG, HRV, EDA\u002FEMG), a short quiet baseline, delivery of both active intervention components, and post-session tolerability\u002Fcomfort ratings. This arm is designed to evaluate the combined effect of active taVNS and active HRV-biofeedback training and to determine whether their combination produces greater benefits than either component alone or than the fully control condition.",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"sham taVNS+control training","SHAM_COMPARATOR","This control condition is delivered over 5 consecutive days, with one supervised 60-minute session per day, and is designed to match the active intervention in schedule, setting, and researcher contact without providing the active therapeutic components. Participants attend the sessions in the same standardized format, but the sham taVNS device placed at the tragus does not deliver active electrical stimulation, and the training condition does not include active HRV-biofeedback or the paced-breathing training intended to consolidate a respiratory rhythm of approximately 6 breaths per minute. This condition is intended to control for expectancy, procedural context, and time spent in session while withholding both active taVNS and active HRV-biofeedback training.",[13],[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"COMBINATION_PRODUCT","LasaiON","Participants will complete one 60-minute session per day. After verification of pre-session requirements, the researcher will place the EEG cap and the HRV, EDA, and EMG sensors and obtain baseline measures. Depending on allocation, participants will receive either active taVNS through stimulation electrodes placed on the auricular target area or sham taVNS using the same device setup without active therapeutic stimulation. From minutes 5-35, participants will remain seated while physiological activity is continuously recorded and they view segmented material from Our Oceans. From minutes 35-50, those allocated to active HRV-biofeedback will use the Coherence Coach platform to learn and practice slow breathing at 6 breaths\u002Fmin, whereas control participants will observe their physiological activity on screen without guided breathing training. Each night at home, intrusive thoughts will be recorded through a brief Google Forms self-report and later analyzed with IRaMuTeQ.",[15,19,9,23],null,[35],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Ainara Aranberri Ruiz, Ph.D.","CONTACT","943018311","ainara.aranberri@ehu.eus",[41],{"facility":42,"status":33,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Euskal Herriko Unibertsitatea","San Sebastián","Gipuzkoa","20018","Spain","ES",{"type":49,"coordinates":50},"Point",[51,52],-5.9,43.56667,{"lat":52,"lon":51},[55,56],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},{"name":57,"role":37,"phone":58,"phoneExt":33,"email":59},"Unai Liberal Graña, PhD","943 01 5224","unai.liberal@ehu.eus",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Ainara Aranberri Ruiz","PhD. Ainara Aranberri, Lead Investigator",[65],{"name":66,"class":67},"Parasym Ltd.","INDUSTRY","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","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":78,"type":79},200,"ESTIMATED","INTERVENTIONAL",[82],"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.",[85],"Adult",[87,88],"slow, paced breathing","transauricualr vagus nerve stimulation","NOT_YET_RECRUITING","2026-03-23",{"date":92,"type":93},"2026-03-27","ACTUAL",{"date":95,"type":79},"2026-03-30",{"date":97,"type":79},"2028-03-30",{"name":5,"class":6},1]