[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552010":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":25,"responsibleParty":41,"collaborators":25,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":25,"eligibilityCriteria":48,"healthyVolunteers":45,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":25,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":25,"overallStatus":61,"whyStopped":25,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":25},{"fullName":5,"class":6},"Chang Gung Memorial Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Hydroxychloroquine group","EXPERIMENTAL","Hydroxychloroquine with steroid",[13,14],"Drug: Hydroxychloroquine","Drug: Steroid",{"label":16,"type":6,"description":17,"interventionNames":18},"Control group","Steroid only",[14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Hydroxychloroquine","Oral hydroxychloroquine (400mg\u002Fday) for 2 months",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Steroid","Oral prednisolone (5 mg) for 2 weeks (1 mg\u002Fkg\u002Fday for one week with gradually taper for another week with or without intratympanic dexamethasone 5 mg\u002Fml injection for 2-4 times)",[16,9],[31],{"name":32,"affiliation":5,"role":33},"Chao-Hui Yang","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Chao-Hui Yang, MD,PhD","CONTACT","88677317123","2531","chouwhay@gmail.com",{"type":42,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100552010","phase-2-efficacy-and-safety-of-hydroxychloroquine-in-the-treatment-of-sudden-sensorineural-hearing-loss-100552010",false,"NCT06467526","Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss","Inclusion Criteria:\n\n1. Unilateral idiopathic sudden sensorineural hearing loss ≥ 30 dB in at least 3 consecutive frequencies, compared to the contralateral ear, within 3 days\n2. Enrollment has to be accomplished within 14 days after SSNHL onset\n3. Male or female aged ≥ 18 to 70 years\n4. Ability to understand and follow the study protocol\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding female\n2. positive pregnancy test before receiving the study drug\n3. Due to a history of physical efforts suspected perilymph fistula or membrane rupture.\n4. Previously existing, known retrocochlear hearing loss\n5. Any history of any ear operation or chronic inflammatory disease of middle ear in the past one year\n6. History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL.\n7. History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops, and otosclerosis.\n8. History of chronic inflammatory diseases or autoimmune diseases\n9. Prior chemotherapy or treatment with immunosuppressant drugs\n10. Patients on renal dialysis\n11. Patients with history of retinopathy, or are using drugs that could induce retinopathy, such as Tamoxifen\n12. History of allergy to hydroxychloroquine\n13. Patients who are contraindicated with oral steroid treatment","ALL","18 Years","70 Years",{"count":53,"type":54},80,"ESTIMATED","INTERVENTIONAL",[57],"PHASE2","Sudden sensorineural hearing loss (SSNHL) is diagnosed when there's a sudden drop in hearing of at least 30 decibels across three consecutive frequencies, emerging within up to 72 hours. In clinical settings, steroids are the predominant treatment for SSNHL. However, the outcomes for patients undergoing steroid therapy for SSNHL can differ substantially. Moreover, a systematic review of randomized clinical trials has found no conclusive evidence pinpointing an effective treatment for SSNHL. Hydroxychloroquine, a derivative of chloroquine, is a medication that has gained attention for its potential role in modulating the immune response. We aim to see if hydroxychloroquine could augment hearing recovery in SSNHL under steroid treatment and to evaluate the safety of hydroxychloroquine in the treatment of SSNHL patients. We plan to enroll 80 SSNHL patients who received oral steroid therapy and randomize them into an experimental group (hydroxychloroquine with prednisolone, 40 patients) and a control group (prednisolone, 40 patients). The primary endpoint will be the change in pure tone audiogram (PTA) in the affected ear from screening until 3 months. The secondary endpoints will be the change in word recognition score and the change in bilateral tinnitus severity after treatment. Any side effects will be recorded to ensure the safety of this clinical trial.",[60],"Sudden Hearing Loss","NOT_YET_RECRUITING","2024-06-16",{"date":64,"type":65},"2024-06-21","ACTUAL",{"date":67,"type":54},"2024-07-01",{"date":69,"type":54},"2027-03-31",{"name":5,"class":6}]