[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603250":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":55,"centralContacts":60,"locations":67,"responsibleParty":93,"collaborators":95,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":65,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":65,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":122,"whyStopped":65,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Eye & ENT Hospital of Fudan University","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: intracochlear triamcinolone acetonide injection","EXPERIMENTAL","intracochlear injection of triamcinolone acetonide through the round window membrane",[13],"Drug: intracochlear triamcinolone acetonide injection",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B: intracochlear dexamethasone injection","intracochlear injection of dexamethasone through the round window membrane",[18],"Drug: intracochlear injection of dexamethasone through the round window membrane",{"label":20,"type":10,"description":21,"interventionNames":22},"Group C: intracochlear dexamethasone injection and intratympanic dexamethasone injection","intracochlear injection of dexamethasone through the round window membrane and intratympanic dexamethasone injection through the tympanic membrane",[23],"Drug: intracochlear dexamethasone injection and intratympanic dexamethasone injection",{"label":25,"type":26,"description":27,"interventionNames":28},"Group D: intratympanic dexamethasone injection","ACTIVE_COMPARATOR","intratympanic dexamethasone injection tympanic membrane，once every other day, for a total of 4 injections.",[29],"Drug: intratympanic dexamethasone injection",[31,38,43,49],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","intracochlear triamcinolone acetonide injection","intracochlear triamcinolone acetonide injection of through the round window membrane",[9],[37],"intracochlear triamcinolone acetonide （40mg\u002Fml, 30μl）injection",{"type":32,"name":16,"description":39,"armGroupLabels":40,"otherNames":41},"intracochlear injection of dexamethasone sodium phosphate through the round window membrane",[15],[42],"intracochlear injection of dexamethasone sodium phosphate（7.5mg\u002Fml, 30μl）through the round window membrane",{"type":32,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"intracochlear dexamethasone injection and intratympanic dexamethasone injection","intracochlear dexamethasone sodium phosphate injection of through the round window membrane, intratympanic dexamethasone sodium phosphate injection through the tympanic membrane",[20],[48],"intracochlear injection of dexamethasone sodium phosphate through the round window membrane (7.5mg\u002Fml, 30μl) and intratympanic dexamethasone sodium phosphate injection (10mg\u002Fml)",{"type":32,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"intratympanic dexamethasone injection","intratympanic dexamethasone sodium phosphate injection (10mg\u002Fml) through tympanic membrane，once every other day, for a total of 4 injections.",[25],[54],"intratympanic dexamethasone sodium phosphate injection (10mg\u002Fml)",[56],{"name":57,"affiliation":58,"role":59},"Yilai Shu, MD, Ph.D","Eye & ENT Hospital, Fudan University, Shanghai, China","PRINCIPAL_INVESTIGATOR",[61],{"name":62,"role":63,"phone":64,"phoneExt":65,"email":66},"Wei Li, MD, Ph.D","CONTACT","0086-18301969566",null,"619liwei@163.com",[68],{"facility":69,"status":65,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Fenyang Road 83","Shanghai","Shanghai Municipality","200031","China","CN",{"type":76,"coordinates":77},"Point",[78,79],121.45806,31.22222,{"lat":79,"lon":78},[82,84,86,88,91],{"name":83,"role":63,"phone":64,"phoneExt":65,"email":66},"Wei Li, MD, PhD",{"name":85,"role":59,"phone":65,"phoneExt":65,"email":65},"Huawei Li, MD, Ph.D",{"name":87,"role":59,"phone":65,"phoneExt":65,"email":65},"Wuqing Wang, MD, Ph.D",{"name":89,"role":90,"phone":65,"phoneExt":65,"email":65},"Haibo Shi, MD, Ph.D","SUB_INVESTIGATOR",{"name":92,"role":90,"phone":65,"phoneExt":65,"email":65},"Xinsheng Huang, MD, Ph.D",{"type":94,"investigatorFullName":65,"investigatorTitle":65,"investigatorAffiliation":65,"oldNameTitle":65,"oldOrganization":65},"SPONSOR",[96,98],{"name":97,"class":6},"Shanghai Zhongshan Hospital",{"name":99,"class":6},"Shanghai Jiao Tong University Affiliated Sixth People's Hospital","100603250","phase-2-intracochlear-injection-of-glucocorticoid-100603250",false,"NCT07134075","Intracochlear Injection of Glucocorticoid","Safety and Efficacy of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Total Sudden Sensorineural Hearing Loss","Inclusion Criteria:\n\nAge between 18 and 65 years Unilateral idiopathic sudden sensorineural hearing loss greater than 95dB at the average of 4 frequencies (500 Hz, 1000 Hz, 2000 Hz and 4000 Hz) in PTA (contralateral hearing is less than 30dB) at the onset of sudden hearing loss Participant who were treated with standard treatment for 14 days, but no recovery was confirmed as type IV (final hearing level with hearing gain of ≤15 dB) at the end of the 14-day treatment\n\nExclusion Criteria:\n\nBilateral sudden sensorineural hearing loss Hearing loss with known causes (e.g., Meniere's disease, retrocochlear pathology, history of otologic surgery, perilymphatic fistula, barotrauma) History in the past 6 months of ototoxic treatment such as chemotherapy, use of loop diuretics, high dose aspirin, etc History of sudden sensorineural hearing loss within the past 2 years History of ischemic diseases (cerebral infarction, myocardial infarction, peripheral arterial obstructive disease) Neuropsychiatric disorders (epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis) Severe hepatic or renal insufficiency The CT diagnosis is \"abnormality of the round window niche\"","ALL","18 Years","65 Years",{"count":111,"type":112},150,"ESTIMATED","INTERVENTIONAL",[115],"PHASE2","This study is a prospective, randomized pilot study. To verify safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with total sudden sensorineural hearing loss safety and efficacy in total sudden sensorineural hearing loss patients as an early salvage therapy.",[118],"Sudden Sensorineural Hearing Loss (SSNHL)",[120,121],"intracochlear injection","glucocorticoid","NOT_YET_RECRUITING","2025-08-14",{"date":125,"type":126},"2025-08-21","ACTUAL",{"date":128,"type":112},"2025-08-25",{"date":130,"type":112},"2027-08-01",{"name":5,"class":6},1]