Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial

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, are currently regularly and standardly applied for ISSNHL to improve the hearing outcome. However, the vestibular prognosis of ISSNHL after routine treatments remains seldom explored. This study aims to compare the effectiveness of oral and 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. Seventy-two patients with ISSNHL complaining of vestibular dysfunction appearing as vertigo or imbalance will be recruited and randomized into either oral or intratympanic glucocorticoid therapy group 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, cervical vestibular evoked myogenic potential, and ocular vestibular evoked myogenic potential; the secondary outcomes include self-reported vestibular dysfunction symptoms; dizziness-related handicap, visual analogue scale for vertigo and tinnitus; and pure tone audiometry. Assessments of primary outcomes will be performed at baseline and at 4 and 8 weeks post-randomization, while assessments of secondary outcomes will be performed at baseline and 1, 2, 4, and 8 weeks post-randomization. Discussion Previous intervention studies of ISSNHL included only hearing outcomes, with little attention paid on the prognosis of vestibular dysfunction. This trial will be the first RCT study focusing on the progress and prognosis of vestibular dysfunction in ISSNHL. The 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 23 July 2019

Clinical efficacy of intratympanic steroid injection for treating idiopathic sudden sensorineural hearing loss

“…13 Compared with systemic steroids, ITSIs can deliver a higher drug concentration to the inner ear, thereby avoiding most of the side effects of oral steroids. 14 The literature findings on the therapeutic effect of ITSIs are inconsistent; various definitions of hearing recovery have been proposed, and various demographics have been examined. 15 Koltsidopoulos et al 8 reported significant hearing recovery in 31 (67.39%) of 46 patients who underwent ITSI treatment.…”

The Role of Asymmetry Values, Gain, and Pathological Saccades of the Video Head Impulse Test (vHIT) in Sudden Sensorineural Hearing Loss

“…Currently, the interpretation of vHIT results primarily relies on the gain value. Several studies have investigated the role of VOR gain in vHIT in patients with SSNHL (13)(14)(15)(16). However, there is limited research on the significance of pathologic saccades in vHIT in SSNHL.…”

Idiopathic Labyrinthitis: Symptoms, Clinical Characteristics, and Prognosis

“…Very few studies have focused on the vestibular recovery in patients with ISSNHL and concurrent vestibulopathy, let alone discuss the influence of glucocorticoids on this vestibular recovery. Hao et al 21 have published a study protocol in 2020 to analyze the short- and long-term vestibular prognosis after ISSNHL with concurrent vertigo, while adjusting for glucocorticoid treatment strategies. This study might clarify the vestibular prognosis after concurrent vestibulopathy and sudden hearing loss.…”