[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sudden-sensorineural-hearing-loss\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sudden-sensorineural-hearing-loss":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,83,109,135,160],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100601643","phase-3-effect-of-aspirin-and-folic-acid-for-sudden-sensorineural-hearing-loss-100601643",false,"NCT07113158","Effect of Aspirin and Folic Acid for Sudden Sensorineural Hearing Loss","SERORL","Inclusion Criteria:\n\n* Unilateral SSNHL defined as a sudden hearing loss of 30dB or greater at least three contiguous audiometric frequencies (between 125hz and 8000Hz) occurring within a 72 hr period and for less than 15 days.\n* Individuals affiliated to a social security regimen\n* Individuals able to participate and to follow up during the study period\n\nExclusion Criteria:\n\n* Contra-indications to Aspirin, contra-indications to oral corticosteroid therapy, contra-indications to dexamethasone, allergy to vitamin B9\n* Evident cause of acute SSNHL including tumor of the ponto-cerebellous angle, infectious labyrinthitis, mechanical and acoustic trauma, malformation of the inner ear, neurological disorder.\n* Patient already including in another clinical trial\n* Person under legal protection (under guardianship or curatorship)\n* Patients taking serotonin reuptake inhibitors\n* Patients already taking aspirin or other anticoagulant or antiplatelet agent","ALL","18 Years","80 Years",{"count":20,"type":21},142,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The annual incidence of sudden sensorineural hearing loss (SSNHL) is 5 to 20 per 100 000 persons. The pathophysiology of SSNHL and acute vestibulo-cochlear syndromes (VCS) is unknown in more than 70% of cases.\n\nHypothesis : an inner ear microvascular disease represents the key element in the pathogenesis of SSNHL and acute VCS.\n\nPlasma serotonin has among other tissular effect a vasospastic on microcirculation such as the inner ear microvascularisation. Increased plasma homocysteine has a deleterious effect on vascular endothelium. Inner ear microvascularisation sensitized by an increased homocysteine level and the vascular wall would vasoconstrict under serotonin stimulation inducing ischemia of the vestibular and\u002For cochlear organs.",[27],"Sudden Sensorineural Hearing Loss",[29,30,31,32,33],"SSNHL","sudden sensorineural hearing loss","sudden hearing loss","aspirin","acid folic","NOT_YET_RECRUITING","2026-01-12",{"date":37,"type":38},"2026-01-14","ACTUAL",{"date":40,"type":21},"2026-04-01",{"date":42,"type":21},"2029-11-01",{"name":44,"class":45},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100535291","phase-1-a-phase-1b2a-study-evaluating-the-safety-pkpd-and-efficacy-of-ns101-in-healthy-volunteers-and-ssnhl-patients-100535291","NCT06249919","A Phase 1b\u002F2a, Study Evaluating the Safety, PK\u002FPD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients","A Phase 1b\u002F2a, Double-blinded, Placebo-controlled, Multiple Doses, 2 Step-up Study Evaluating the Safety, Tolerability, PK\u002FPD and Efficacy of Systemic NS101 in Healthy Volunteers and SSNHL Patients","Part A: healthy volunteers\n\nPart B:\n\nInclusion Criteria:\n\n* unilateral ideopathic SSNHL greater than 45dB at the average of 4 frequencies in PTA (contralateral hearing is less than 30dB)\n* Subject who has completed investigator-recognized standard treatment within 30 days of symptom onset and is able to undergo randomization visit within 35 days.\n* Subjects who, in the opinion of the investigator, have received sufficient systemic steroid therapy for approximately 2 weeks recovery\n* A combination regimen consisting of approximately 2 weeks of systemic steroid therapy and intratympanic steroid administration\n\nExclusion Criteria:\n\n* other otologic or systemic diseases\n* retrocochlear lesion",true,"19 Years","70 Years",{"count":58,"type":21},138,[60,61],"PHASE1","PHASE2","The goal of this 2 step-up, exploratory study is to test safey, tolerability and PK\u002FPD profiles in healthy volunteers and safety, tolerability and efficacy in sudden sensorineural hearing loss patients as an early salvage therapy.\n\nThe main questions it aims to answer are:\n\n1. whether is it safe and tolerable when healthy volunteers and sudden sensorineural hearing loss patients take multiple doses of NS101 against FAM19A5\n2. whether is it effective in reversing hearing capability in sudden sensorineural hearing loss patients who fails to show sufficient recovery despite of oral standard steroid therapy.\n\nPatients and heathly volunteers will be given NS101 15mg\u002Fkg or 30mg\u002Fkg systemically less than 3 months per protocol.\n\nThis is placebo controlled, double blinded study, which means there will be a group who receives placebo (i.e. fake drug) for study purpose.",[64,27],"Seneorineural Deafness",[66,30,67,68,69,70],"Sensorineural disease","sensorineural hearing loss","sudden deafness","cochlear synaptopathy","hidden auditory synaptopathy","RECRUITING","2025-08-07",{"date":74,"type":38},"2025-08-13",{"date":76,"type":38},"2024-01-19",{"date":78,"type":21},"2027-01-31",{"name":80,"class":81},"Neuracle Science Co., LTD.","INDUSTRY",16,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":46},"100598154","phase-3-evaluation-of-oral-corticosteroid-therapy-in-idiopathic-sudden-unilateral-hearing-loss-100598154","NCT07067801","Evaluation of Oral Corticosteroid Therapy in Idiopathic Sudden Unilateral Hearing Loss.","Evaluation of Oral Corticosteroid Therapy in Idiopathic Sudden Unilateral Hearing Loss; a Randomized, Double Blind, Futility (Non-superiority) Trial.","ECOSUB","Inclusion Criteria:\n\n* Men and women at least 18 years of age\n* ISSNH: idiopathic unilateral sensorineural hearing loss occurring in less than 72 hours, with loss of at least 30dB on 3 consecutive frequencies compared with the norm or the contralateral ear, confirmed on audiogram.\n* Hearing loss beginning no more than 10 days ago\n* Signed informed consent indicating that the subject has understood the purpose and procedures of the study, and agrees to participate in the study and to abide by its requirements and restrictions\n* Affiliation with a French social security scheme or beneficiary of such a scheme\n\nExclusion Criteria:\n\n* Otological medical history, illness or treatment affecting hearing\n* Pregnancy\n* Recurrent ISSNH\n* Contraindication to oral corticosteroids or already treated with long-term corticosteroids\n* Neurological symptoms other than vertigo or tinnitus\n* Persons deprived of liberty by judicial or administrative decision; persons under forced psychiatric care; persons admitted to a health or social establishment for purposes other than research.\n* Adults under legal protection or unable to express their consent\n* Subjects who have been excluded from another study or who are on the \"national volunteer list\".\n* Exclusion criteria during the course of the study : discovery of vestibular schwannoma, or other pathology explaining the SUB, on MRI centered on the internal auditory canals and cerebellopontine angles prescribed as part of routine care.",{"count":92,"type":21},430,[24],"Context: Idiopathic Sudden Sensorineural Hearing Loss (ISSHL) is a rapid-onset, sensorineural hearing loss of unknown etiology. It is one of the most common ENT emergencies, with spontaneous recovery occurring in 32% to 65% of cases. Treatment remains controversial, and the need for treatment itself is debated. Oral corticosteroids (OCS) are commonly used as first-line therapy, although they may have short-term side effects. Intratympanic corticosteroid injections (ITCIs) are an option for patients with contraindications to OCS or as a salvage treatment. The most recent Cochrane review includes three placebo-controlled studies on OCS efficacy (totaling 267 patients): two found no superiority of OCS, while one showed improvement in hearing. These studies are inconsistent and present methodological biases. Therefore, a sufficiently powered study is needed to assess OCS efficacy and establish clear treatment recommendations for ISSHL.\n\nObjectives: Primary Objective: To demonstrate the equivalence of OCS as first-line treatment for ISSHL compared to no treatment, in terms of hearing recovery between days 7 and 10. Secondary Objectives: To assess the effect of OCS versus no treatment on tinnitus, and hearing recovery based on initial severity of ISSHL. To evaluate hearing recovery in patients treated with rescue ITCIs. In the absence of equivalence, to investigate the superiority of OCS over no treatment.\n\nMethods: This multicenter, randomized, controlled equivalence trial will include two arms, each with 215 patients: one receiving OCS and the other a no-treatment control. In the absence of early hearing improvement, ITCIs will be administered regardless of study arm.\n\nPerspective: The goal is to clarify the role of OCS in treating ISSHL and guide the development of updated treatment recommendations.",[27],[27,97,98,99],"Corticosteroids","Randomized clinical trial","Placebo","2025-07-21",{"date":102,"type":38},"2025-07-24",{"date":104,"type":21},"2025-11",{"date":106,"type":21},"2028-12",{"name":108,"class":45},"Centre Hospitalier Universitaire de Besancon",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":46},"100590522","phase-4-comparison-of-the-effectiveness-of-oral-and-intratympanic-corticosteroid-treatments-in-patients-diagnosed-with-sudden-sensorineural-hearing-loss-100590522","NCT06968507","Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss","Inclusion Criteria:\n\n* 18 years of age and older\n* Unilateral sudden sensorineural hearing loss that developed within 72 hours and has lasted for 14 days or less\n* Affected side PTA (500-100-2000-4000hz) should be over 50dB\n* Affected side should be at least 30dB lower than healthy side in 3 frequencies\n* Hearing should be symmetrical according to patient's statement before sensorineural hearing loss\n* If used, steroid use should be less than 10 days\n* Cerebellar and vestibular examination should be normal\n\nExclusion Criteria:\n\n* Having a history of hearing-related surgery other than a ventilation tube\n* Having a history of previous hearing loss, fluctuating hearing or Meniere's disease, chronic inflammatory or suppurative ear disease or cholesteatoma, otosclerosis\n* Being under 18 or over 80\n* Having a history of physical-barotrauma\n* Presence of structural or retrocochlear pathology in the examination and imaging that would explain the unilateral hearing loss\n* Patients diagnosed with tuberculosis or receiving prophylactic tuberculosis treatment, diabetes mellitus, rheumatological patients, those with atherosclerotic disease, serious psychiatric patients, those receiving chemotherapy, radiotherapy or immunosuppressant treatment, pancreatitis patients, HIV, hepatitis C and B patients, those with chronic renal failure, substance abusers, those with active herpetic lesions, severe osteoporosis patients, those with hearing loss within 4 weeks after general anesthesia, those with a history of head and neck cancer.",{"count":116,"type":21},214,[118],"PHASE4","The goal of this clinical trial is to learn which one works to treat better in patients with sudden sensorineural hearing loss, oral or intratympanic corticosteroid treatment.\n\nThe main question it aims to answer is:\n\nWhich corticosteroid treatment is more effective in patients with sudden sensorineural hearing loss, oral or intratympanic?\n\n* In our study, it was planned to divide the treatment schemes compared into two groups. Group 1 included patients who received oral methylprednisolone treatment daily for 2 weeks (48 mg for the first 7 days, 32 mg for the following 2 days, 16 mg for the 2 days, and 8 mg for the last 3 days). Group 2 included patients who received intratympanic 8 mg\u002F2 ml dexamethasone every other day, totally 4 doses.\n* Visit the clinic after diagnose in first week, second week, first month and second month for checkups and tests ( temporal MR, odimetric results)",[27],[122,123,124],"intratympanic dexamethasone","Sudden sensorineural hearing loss","oral methylprednisolone","2025-05-05",{"date":127,"type":38},"2025-05-13",{"date":129,"type":21},"2025-05-20",{"date":131,"type":21},"2028-09-10",{"name":133,"class":134},"Dr. Lutfi Kirdar Kartal Training and Research Hospital","OTHER_GOV",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":46},"100425919","phase-4-oral-statins-and-protection-from-hearing-loss-100425919","NCT04826237","Oral Statins and Protection From Hearing Loss","Towards a Self-Administered Hearing Protection Regimen","Inclusion Criteria:\n\n* Patient older than 18 years and younger than 81 years and\n* Diagnosed with one sided idiopathic sudden sensorineural hearing loss by physical examination, history, audiology, speech interpretation tests and tinnitus evaluation and\n* Seen in the clinic within the first 14 days after the onset of symptoms. and\n* Mean hearing threshold equal to or worse than \\>30 dB averaged across three consecutive frequencies.\n* Excellent English Speaking and Comprehension\n\nExclusion Criteria:\n\n* Children\n* Prisoners\n* Pregnant women\n* Patients who have experienced similar prior events of SSNHL\n* Patients with bacterial infections, mycoplasma, Lyme disease, tuberculosis, syphilis, fungal infections,\n* Autoimmune inner ear disease\n* Middle ear inflammation or effusion\n* Ototoxic medication such as chemotherapy, loop diuretics, high dose aspirin, etc.\n* Head Trauma, lead poisoning\n* Genetic disorders affecting hearing\n* Mitochondrial disorders, including MELAS (metabolic encephalopathy, lactic acidosis, and stroke-like episodes), stroke, Cogan's syndrome\n* Neoplastic (neurofibromatosis II, bilateral vestibular schwannomas, carcinomatous meningitis, intravascular lymphomatosis, others)\n* Sarcoidosis\n* Hyperviscosity syndrome\n* Diabetes\n* Use of statins within the last 12 months\n* Allergy, hypersensitivity or intolerance to any components of the study medication\n* Prior tinnitus\n* Prior otologic surgery other than ventilation tubes\n* History of drug abuse or alcoholism within the prior 2 years\n* Any psychiatric syndrome requiring treatment with neuroleptics, antidepressants, hypnotics or anxiolytics\n* Severe systemic neurologic disease (epilepsy, Parkinson's, dementia\u002FAlzheimers, multiple sclerosis\n* Oral steroid treatment within the preceding 30 days\n* Heart disease or TIAs\n* Chronic kidney failure\n* HIV, Hepatitis B or C\n* Active shingles\n* Skull, facial or temporal bone anomalies",{"count":143,"type":21},100,[118],"A small clinical trial for idiopathic sudden sensorineural hearing loss (ISSNHL). Will the addition of an oral statin to the standard treatment (oral methylprednesolone and the salvage therapy of intratympanic dexamethasone) improve the treatment outcome for patients with ISSNHL? This study will compare the two treatments and quantitatively evaluate hearing and speech discrimination and have the patients subjectively evaluate tinnitus.",[27],[148,149,150],"deafness","statin","hearing loss","2024-12-03",{"date":153,"type":38},"2024-12-05",{"date":155,"type":38},"2023-02-09",{"date":157,"type":21},"2025-12-31",{"name":159,"class":45},"Northwestern University",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":54,"sex":16,"minAge":167,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":171,"phases":4,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":4},"100544199","multi-omics-characteristics-and-prognosis-of-idiopathic-sudden-sensorineural-hearing-loss-100544199","NCT06365775","Multi-omics Characteristics and Prognosis of Idiopathic Sudden Sensorineural Hearing Loss","Multi-omics Characteristics and Prognosis in Patients With Idiopathic Sudden Sensorineural Hearing Loss","Inclusion Criteria:\n\n* Age ≥ 4\n* Participants with SSNHL: unilateral or bilateral sensorineural hearing loss of \\> 30 dB HL (decibel) involving at least 3 continuous test frequencies developing within 72 hours\n* Healthy controls: people with PTA thresholds of all test frequencies ≤ 20 dB HL and without otologic disease in the last 3 months\n* Completed informed consent and promised to finish follow-ups\n\nExclusion Criteria:\n\n* Hearing loss with explicit causes, including noise-induced, Ménière's disease, ototoxicity exposure, mumps infection or history of syphilis infection and so on.\n* A history of head trauma or otologic surgery.\n* Malformation of temporal bone discovered by computed tomography (CT)\n* Retro-cochlear lesion discovered by magnetic resonance imaging (MRI)\n* Pregnant women","4 Years","65 Years",{"count":170,"type":21},400,"OBSERVATIONAL","The goal of this observational study is to describe the multi-omics characteristics and to learn about the prognostic factors in patients with idiopathic sudden sensorineural hearing loss (SSNHL). The main problems it aims to deal with are:\n\n* if there is a difference in data of exome and targeted sequencing among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls\n* if there is a difference in the parameter of MRI among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls\n* to find out which factor from multi-omics data relates to outcomes of SSNHL\n* to develop the best prognostics model based on the multi-omics data.\n\nParticipants will be received audiological tests, blood specimen collection and radiological examination. Researchers will explore the relationship between the multi-omics data and the prognosis and develop the predictive model.",[27,174,175],"Hearing Loss, Sensorineural","Hearing Loss, Sudden","2024-04-09",{"date":178,"type":38},"2024-04-15",{"date":180,"type":21},"2024-04-23",{"date":182,"type":21},"2026-11-23",{"name":184,"class":45},"Dan Bing"]