[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569621":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":25,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":25,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Beijing Tongren Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"taVNS group","EXPERIMENTAL","taVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients.\n\nStimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. The electrodes were placed on the cymba conchae and concha around the affected ear, which is the region of rich vagus nerve branch distribution.",[13,14],"Device: Transcutaneous Auricular Vagus Nerve Stimulation","Drug: 0.1% sodium hyaluronate eye drop",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group","SHAM_COMPARATOR","taVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients.\n\nStimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. The electrodes were placed on the cymba conchae and concha around the affected ear, which is the region of rich vagus nerve branch distribution. Patients in control group were applied using the same stimulator, stimulation parameters and same sessions. However, the electrodes were placed on the antihelix around the affected ear, which is the region of few vagus nerve branch distribution.",[13,14],[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DEVICE","Transcutaneous Auricular Vagus Nerve Stimulation",[16,9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DRUG","0.1% sodium hyaluronate eye drop","Participants received 0.1% sodium hyaluronate eye drop (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany).",[16,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Dong Wu, Doctor","CONTACT","8613810988682","wudong0120@outlook.com",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"China Beijing TongRen Hospital, Capital Medical University Beijing, China","RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},[53],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100569621","transcutaneous-auricular-vagus-nerve-stimulation-in-dry-eye-100569621",false,"NCT06696625","Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye","Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye: a Randomized Clinical Trial","Inclusion Criteria:\n\n1. Age \\>=18 and Age \\\u003C=65.\n2. complaint of DED symptoms for 6 months or longer at screening.\n3. ocular surface disease index (OSDI) score of 25 or higher.\n4. tear film breakup time (TFBUT) of 5 seconds or less.\n5. Schirmer I test without anesthesia of 5 mm or more at 5 minutes.\n6. tCFS score of 4 or higher.\n\nExclusion Criteria:\n\n1. History systemic autoimmune diseases and ocular\u002Fperiocular malignancy.\n2. Clinically relevant slitlamp findings or abnormal lid anatomy.\n3. Active ocular allergies and active infection.\n4. Pregnant or lactating women.","ALL","18 Years","65 Years",{"count":67,"type":68},256,"ESTIMATED","INTERVENTIONAL",[71],"NA","Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease.\n\nMethods: The investigators enrolled 256 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months. OSDI score, TBUT, Schirmer I, CFS, SF36, DEQ5, and psychological status to evaluate the therapeutic effects. A difference of P \\\u003C 0.05 was considered statistically significant.",[74],"Dry Eye Disease",[76,77,78],"taVNS","Dry eye","RCT","2024-11-18",{"date":81,"type":82},"2024-11-20","ACTUAL",{"date":84,"type":82},"2021-07-01",{"date":86,"type":68},"2025-12-01",{"name":5,"class":6},1]