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โ† Trials
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Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss

RecruitingPhase 2Ages 18 Years - 70 YearsAllChang Gung Memorial Hospital
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Unilateral idiopathic sudden sensorineural hearing loss โ‰ฅ 30 dB in at least 3 consecutive frequencies, compared to the contralateral ear, within 3 days 2. Enrollment has to be accomplished within 14 days after SSNHL onset 3. Male or female aged โ‰ฅ 18 to 70 years 4. Ability to understand and follow the study protocol Exclusion Criteria: 1. Pregnant or breast-feeding female 2. positive pregnancy test before receiving the study drug 3. Due to a history of physical efforts suspected perilymph fistula or membrane rupture. 4. Previously existing, known retrocochlear hearing loss 5. Any history of any ear operation or chronic inflammatory disease of middle ear in the past one year 6. History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL. 7. History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops, and otosclerosis. 8. History of chronic inflammatory diseases or autoimmune diseases 9. Prior chemotherapy or treatment with immunosuppressant drugs 10. Patients on renal dialysis 11. Patients with history of retinopathy, or are using drugs that could induce retinopathy, such as Tamoxifen 12. History of allergy to hydroxychloroquine 13. Patients who are contraindicated with oral steroid treatment
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What it tests

  • Hydroxychloroquine
  • Steroid
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Where

1 site
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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