[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647689":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":41,"centralContacts":67,"locations":76,"responsibleParty":93,"collaborators":41,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":41,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":41,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":79,"whyStopped":41,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Tzu Chi University","OTHER",[8,13,18,24,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Foot Reflexology - True (n=36)","EXPERIMENTAL","Procedure: True Foot Reflexology",[11],{"label":14,"type":15,"description":16,"interventionNames":17},"Arm B: Foot Reflexology - Sham (n=36)","SHAM_COMPARATOR","Procedure: Sham Foot Reflexology",[16],{"label":19,"type":10,"description":20,"interventionNames":21},"Arm C: ta-VNS - True (n=36)","Device: True ta-VNS + Procedure: Auricular Acupressure",[22,23],"Device: True ta-VNS","Procedure: True Auricular Acupressure",{"label":25,"type":15,"description":26,"interventionNames":27},"Arm D: ta-VNS - Sham (n=36)","Device: Sham ta-VNS + Procedure: Sham Auricular Acupressure",[28,29],"Device: Sham ta-VNS","Procedure: Sham Auricular Acupressure",{"label":31,"type":32,"description":33,"interventionNames":34},"Arm E: Usual Care (n=36)","ACTIVE_COMPARATOR","Other: Usual Care",[33],[36,42,46,51,55,59,63],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"PROCEDURE","True Foot Reflexology","Once weekly, 20 min, 4 sessions over 1 month. Three phases: relaxation (diaphragm, brain, spine reflex zones, 3 min); inner-ear and autonomic regulation (inner ear, hypothalamus, cerebellum, brainstem, thyroid, adrenal zones, 10 min); circulation\u002Fdetoxification (kidney, lymphatic zones, 7 min).",[9],null,{"type":37,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"Sham Foot Reflexology","Light touch on non-specific foot areas (dorsum, anterior ankle, foot margins) without effective pressure.",[14],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":41},"DEVICE","True ta-VNS","Left tragus, cymba conchae, cavum conchae; 250 µs, 25 Hz, 0.5-5 mA individualized to tingling, 30 s on\u002Foff; once weekly, 20 min, 4 weeks. Device: Hong-Tai mid-frequency electrotherapy stimulator, model HT66B (TFDA license no. 000637), used off-label for auricular vagus nerve stimulation.",[19],{"type":47,"name":52,"description":53,"armGroupLabels":54,"otherNames":41},"Sham ta-VNS","Left earlobe, 0.5 mA, otherwise identical parameters (250 µs, 25 Hz, 30 s on\u002Foff).",[25],{"type":37,"name":56,"description":57,"armGroupLabels":58,"otherNames":41},"True Auricular Acupressure","Magnetic beads (1-2 mm) at left tragus, cymba conchae, cavum conchae; pressed 3×\u002Fday, \\~30 s per point; changed every 2-3 days.",[19],{"type":37,"name":60,"description":61,"armGroupLabels":62,"otherNames":41},"Sham Auricular Acupressure","Beads at left earlobe (non-vagal regions), same frequency\u002Fduration.",[25],{"type":6,"name":64,"description":65,"armGroupLabels":66,"otherNames":41},"Usual Care","Standard tinnitus clinical care (pharmacologic and supportive); no study intervention.",[31],[68,73],{"name":69,"role":70,"phone":71,"phoneExt":41,"email":72},"Yu-Fu Chou MD","CONTACT","886-3-8561825","yufuchou@yahoo.com.tw",{"name":74,"role":70,"phone":41,"phoneExt":41,"email":75},"Chun-Hou Huang","hou2017@gms.tcu.edu.tw",[77],{"facility":78,"status":79,"city":80,"state":41,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Hualien Tzu Chi Hospital, Department of Otorhinolaryngology","RECRUITING","Hualien City","970","Taiwan","TW",{"type":85,"coordinates":86},"Point",[87,88],121.60444,23.97694,{"lat":88,"lon":87},[91],{"name":92,"role":70,"phone":71,"phoneExt":41,"email":75},"Yu-Fu Chou Chou, MD",{"type":94,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"PRINCIPAL_INVESTIGATOR","Chun Hou Huang","Associate Professor","100647689","fr-tavns-tinnitus-tria-100647689",false,"NCT07711639","FR-taVNS Tinnitus Tria","Efficacy of Foot Reflexology and Transcutaneous Auricular Vagus Nerve Stimulation on Tinnitus in Non-Cancer Adult Populations","Inclusion Criteria:\n\n* Age 18-75 years, conscious, able to communicate and comprehend, and able to complete questionnaires and comply with study procedures\n* Tinnitus as the sole chief complaint, with pure-tone thresholds ≤25 dB HL bilaterally at 500, 1000, 2000, and 4000 Hz\n\nExclusion Criteria:\n\n* Objective tinnitus, peripheral vestibular disease, central nervous or cardiovascular causes, or other organic ear pathology\n* Open wounds or skin lesions of the foot or ear, lower-limb edema, history of deep vein thrombosis, or diabetes with most recent HbA1c \\>7.5%\n* Cardiac pacemaker or other implanted electronic device, or other severe cardiovascular disease\n* Foot reflexology or vagus nerve stimulation within the past 3 months\n* Pregnant or breastfeeding women\n* History of epilepsy or seizures\n* Physically frail condition","ALL","18 Years","75 Years",{"count":108,"type":109},180,"ESTIMATED","INTERVENTIONAL",[112],"NA","Tinnitus is a common neurosensory symptom affecting 12-30% of adults and is closely associated with anxiety, sleep disturbance, and autonomic dysregulation. Current pharmacologic treatments offer limited efficacy and notable side effects, prompting interest in non-pharmacological approaches. This randomized, single-blind, sham-controlled trial evaluates whether foot reflexology (FR), transcutaneous auricular vagus nerve stimulation (ta-VNS), and auricular acupressure (AA) improve tinnitus severity, psychological distress, sleep quality, and autonomic indicators (heart rate variability and salivary cortisol) in non-cancer adults with tinnitus, compared with usual care. Participants are randomized to a foot reflexology group, an auricular vagus nerve stimulation group (each with true and sham subgroups), or a usual-care control group, and are followed at baseline and weeks 2, 4, and 8.",[115],"Tinnitus",[117,118,119,120,115,121,122,123,124],"Foot Reflexology","Transcutaneous Auricular Vagus Nerve Stimulation","ta-VNS","Auricular Acupressure","Heart Rate Variability","Salivary Cortisol","Sleep Quality","Non-pharmacological intervention","2026-07-23",{"date":127,"type":128},"2026-07-24","ACTUAL",{"date":130,"type":128},"2026-04-28",{"date":132,"type":109},"2028-12-31",{"name":5,"class":6},1]