Abstract
Background Idiopathic sudden sensorineural hearing loss (ISSNHL) is a rapid-onset sensorineural hearing impairment with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction has been considered as a poor indicator in the clinical manifestations and prognosis of ISSNHL, which occurred in approximately 28%-57% cases. Glucocorticoids, administered through oral or intratympanic way, is currently a regular and standard treatment for ISSNHL based on hearing outcome. However, little investigations have been conducted on the recovery process and treatment effects of glucocorticoids on vestibular dysfunctions of ISSNHL. This study aims to compare the efficacy of oral or intratympanic glucocorticoids in ISSNHL with vestibular dysfunction in terms of the pattern and trajectory of possible process of vestibular function recovery.Methods/Design A randomized, outcome-assessor- and analyst-blinded, controlled, clinical trial (RCT) will be carried out. A group of seventy-two patients with ISSNHL complaining of vestibular dysfunction appearing as vertigo, dizziness or imbalance will be recruited and randomized into two arms of either oral or intratympanic glucocorticoids therapy with a 1:1 allocation ratio. The primary outcomes will be vestibular function outcomes assessed by sensory organization test, caloric test, video head impulse test, and vestibular evoked myogenic potentials; the secondary outcomes include self-reported vestibular dysfunction symptoms; dizziness-related handicap, visual analogue scale for vertigo and tinnitus; and pure tone audiometry. Assessment will be performed at baseline and at 1, 2, 4, and 8 weeks post-randomization. To our knowledge, this will be the first randomized controlled trial focusing on the prognosis of vestibular dysfunction in ISSNHL and the efficacy of glucocorticoids therapy for the vestibular dysfunction in this disease.Discussion This trial will be the first RCT study focusing on the progress and prognosis of vestibular dysfunction in ISSNHL. Efficacy of two commonly used therapies of glucocorticoids will be compared in both auditory and vestibular function fields, rather than in the hearing outcome alone. Trial registration ClinicalTrials.gov, NCT03974867. Registered on July 23, 2019.
Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial