[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601643":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":84,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Investigational medicinal products","EXPERIMENTAL","Aspirin 100 mg\u002Fday and Acid Folic 5 mg\u002Fday + gold standard treatment (oral corticosteroid therapy 1 mg\u002Fkg +\u002F- 3 trans-tympanic injections of dexamethasone)\n\n* Corticosteroid therapy 1mg\u002Fkg\u002Fday for 7 days\n* 3 trans-tympanic injections of corticosteroids if hearing loss persists at D15 Duration of treatment: 3 months",[13],"Drug: Aspirin + Acid folic",{"label":15,"type":16,"description":17,"interventionNames":18},"Comparator treatment","PLACEBO_COMPARATOR","The Placebo Aspirin 100 mg\u002Fj + Placebo folic acid 5 mg\u002Fj + reference treatment (oral corticosteroid therapy 1mg\u002Fkg +\u002F- 3 trans-tympanic injections of dexamethasone)\n\n* Corticosteroid therapy 1mg\u002Fkg\u002Fday for 7 days\n* 3 trans-tympanic injections of corticosteroids if hearing loss persists at D15 Duration of treatment: 3 months",[19],"Drug: Placebo Aspirin + Placebo Acid folic",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Aspirin + Acid folic","Aspirin 100 mg\u002Fday and Acid Folic 5 mg\u002Fday + gold standard treatment",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Aspirin + Placebo Acid folic","The Placebo Aspirin 100 mg\u002Fj + Placebo folic acid 5 mg\u002Fj + reference treatment",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Charlotte HAUTEFORT, Dr","CONTACT","0149958062","charlotte.hautefort@aphp.fr",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Ludovic DROUET","0149956414","ludovic.drouet-ext@aphp.fr",[42],{"facility":43,"status":26,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Lariboisière Hospital","Paris","Île-de-France Region","75010","France","FR",{"type":50,"coordinates":51},"Point",[52,53],2.3488,48.85341,{"lat":53,"lon":52},[56],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":70,"type":71},142,"ESTIMATED","INTERVENTIONAL",[74],"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.",[77],"Sudden Sensorineural Hearing Loss",[79,80,81,82,83],"SSNHL","sudden sensorineural hearing loss","sudden hearing loss","aspirin","acid folic","NOT_YET_RECRUITING","2026-01-12",{"date":87,"type":88},"2026-01-14","ACTUAL",{"date":90,"type":71},"2026-04-01",{"date":92,"type":71},"2029-11-01",{"name":5,"class":6},1]