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.
Unilateral idiopathic sudden sensorineural hearing loss ≥ 30 dB in at least 3 consecutive frequencies, compared to the contralateral ear, within 3 days
Enrollment has to be accomplished within 14 days after SSNHL onset
Male or female aged ≥ 18 to 70 years
Ability to understand and follow the study protocol
Pregnant or breast-feeding female
positive pregnancy test before receiving the study drug
Due to a history of physical efforts suspected perilymph fistula or membrane rupture.
Previously existing, known retrocochlear hearing loss
Parallel
Hydroxychloroquine
DrugOral hydroxychloroquine (400mg/day) for 2 months
Steroid
DrugOral prednisolone (5 mg) for 2 weeks (1 mg/kg/day for one week with gradually taper for another week with or without intratympanic dexamethasone 5 mg/ml injection for 2-4 times)
Hearing improvement
To evaluate if hydroxychloroquine could increase the hearing improvement
Word recognition score
To evaluate if hydroxychloroquine could increase the word recognition score
Tinnitus severity
To evaluate if hydroxychloroquine could decrease the tinnitus severity
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