[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655679":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":45,"studyPopulation":35,"armGroups":46,"interventions":59,"overallOfficials":65,"centralContacts":72,"locations":83,"responsibleParty":106,"collaborators":108,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":35,"eligibilityCriteria":118,"healthyVolunteers":115,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":35,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":135,"whyStopped":35,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Eye & ENT Hospital of Fudan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":35},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline in pure tone audiometry (PTA)","hearing capacity of thresholds ( PTA)","Baseline , Week2 , Week4, Week12, Week24.",{"measure":14,"description":15,"timeFrame":16},"Change from Baseline in Speech Discrimination Scores","hearing capacity of thresholds ( speech discrimination )","Baseline , Week4, Week12, Week24.",[18,22,25,29,32],{"measure":19,"description":20,"timeFrame":21},"Change from Baseline in auditory brainstem re-sponse (ABR)","hearing capacity of thresholds ( ABR)","Baseline, Week12",{"measure":23,"description":24,"timeFrame":21},"Change from Baseline in auditory steady-state response (ASSR)","hearing capacity of thresholds (ASSR)",{"measure":26,"description":27,"timeFrame":28},"change from baseline in tinnitus handicap inventory","The scales assess changes in tinnitus","Baseline, Week2, Week4, Week12, Week24",{"measure":30,"description":31,"timeFrame":28},"change from baseline in dizziness handicap inventory","The scales assess changes in vertigo",{"measure":33,"description":34,"timeFrame":28},"change from baseline in quality of life score","The scales assess changes in quality of life",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":35,"timePerspective":35,"maskingInfo":41},"RANDOMIZED","PARALLEL","Parallel Assignment","TREATMENT",{"masking":42,"maskingDescription":35,"whoMasked":43},"SINGLE",[44],"OUTCOMES_ASSESSOR","1. Whether is it safe when profound or complete sudden sensorineural hearing loss patients receive intracochlear injection of glucocorticoid through the round window membrane.\n2. Whether is it effective in reversing hearing capability when profound or complete sudden sensorineural hearing loss patients receive intracochlear injection of glucocorticoid through the round window membrane.\n3. Whether is intracochlear glucocorticoid injection more effective than intratympanic glucocorticoid injection for treating profound or complete sudden sensorineural hearing loss.\n4. Which glucocorticoid intracochlear injection is more effective in patients with profound or complete sudden sensorineural hearing loss.",[47,53],{"label":48,"type":49,"description":50,"interventionNames":51},"Group 1：intracochlear dexamethasone injection","EXPERIMENTAL","intracochlear injection of triamcinolone acetonide through the round window membrane",[52],"Drug: intracochlear injection of triamcinolone acetonide through the round window membrane",{"label":54,"type":55,"description":56,"interventionNames":57},"Group 2: intratympanic dexamethasone injection","ACTIVE_COMPARATOR","intratympanic dexamethasone injection through the tympanic membrane",[58],"Drug: intratympanic dexamethasone injection through the tympanic membrane",[60,63],{"type":61,"name":50,"description":50,"armGroupLabels":62,"otherNames":35},"DRUG",[48],{"type":61,"name":56,"description":56,"armGroupLabels":64,"otherNames":35},[54],[66,70],{"name":67,"affiliation":68,"role":69},"Yilai Shu, MD, Ph.D","Eye & ENT Hospital, Fudan University, Shanghai, China","PRINCIPAL_INVESTIGATOR",{"name":71,"affiliation":68,"role":69},"Huawei Li, MD, Ph.D",[73,78],{"name":74,"role":75,"phone":76,"phoneExt":35,"email":77},"Wei Li, MD, Ph.D","CONTACT","0086-18301969566","619liwei@163.com",{"name":79,"role":75,"phone":80,"phoneExt":81,"email":82},"Wuqing Wang, MD, Ph.D","0086-02164377134","86-02164377134","wwuqing@eent.shmu.edu.cn",[84],{"facility":85,"status":35,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Eye and ENT Hospital, Fudan University","Shanghai","Shanghai Municipality","200031","China","CN",{"type":92,"coordinates":93},"Point",[94,95],121.45806,31.22222,{"lat":95,"lon":94},[98,100,102,103,105],{"name":99,"role":75,"phone":76,"phoneExt":35,"email":77},"Wei Li, MD, PhD",{"name":101,"role":75,"phone":81,"phoneExt":35,"email":82},"Wuqing Wang, MD, PhD",{"name":67,"role":69,"phone":35,"phoneExt":35,"email":35},{"name":104,"role":69,"phone":35,"phoneExt":35,"email":35},"Huawei Li",{"name":79,"role":69,"phone":35,"phoneExt":35,"email":35},{"type":107,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[109,111],{"name":110,"class":6},"Shanghai Zhongshan Hospital",{"name":112,"class":6},"Shenzhen Second People's Hospital","100655679","phase-2-efficacy-and-safety-of-intracochlear-injection-of-glucocorticoid-through-the-round-window-membrane-in-patients-with-profound-or-complete-sudden-sensorineural-hearing-loss-100655679",false,"NCT07814677","Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss","Inclusion Criteria:\n\n* Age between 12 and 75 years Unilateral idiopathic sudden sensorineural hearing loss diagnosed by Pure tone test, CT and MRI Symptoms of sudden deafness occur within ≥ 7 days and, after conventional treatment, the average thresholds at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz are ≥ 80 dBHL\n\nExclusion Criteria:\n\n* Bilateral 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.\n\nHistory 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","12 Years","75 Years",{"count":123,"type":124},56,"ESTIMATED","INTERVENTIONAL",[127],"PHASE2","Safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with profound or complete sudden sensorineural hearing loss",[130],"Sudden Hearing Loss",[132,133,134],"intracochlear injection","glucocorticoid","round window membrane","NOT_YET_RECRUITING","2026-09-06",{"date":138,"type":139},"2026-09-11","ACTUAL",{"date":141,"type":124},"2026-09-15",{"date":143,"type":124},"2028-12-15",{"name":5,"class":6},1]