Sudden Hearing Loss Clinical Trial
Official title:
Vestibular Prognosis Assessment of the Idiopathic Sudden Sensorineural Hearing Loss With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids
Idiopathic sudden sensorineural hearing loss (ISSNHL) is a complicated hearing impairment
with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction like vertigo
has been considered as a risk factor of profound hearing loss and poor prognosis in ISSNHL.
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 recovery process and treatment effects of glucocorticoids on vestibular
dysfunctions of ISSNHL. This study aims to evaluate the recovery pattern and possible process
of vestibular system in ISSNHL with vestibular dysfunction, and to compare the efficacy of
oral or intratympanic glucocorticoids in these participants.
A randomized, outcome assessor- and statistical analyst-blinded, controlled, clinical trial
will be carried out. 72 patients complaining of vestibular dysfunction appearing as vertigo,
dizziness, imbalance or lateropulsion with ISSNHL will be recruited and randomized into two
arms of oral or intratympanic glucocorticoids therapy in 1:1 allocation. The primary outcomes
will be subjective feelings evaluated by duration of vestibular dysfunction symptoms,
dizziness-related handicap, visual analogue scale for vertigo, and objective vestibular
function tests results assessed by sensory organization test, caloric test, video head
impulse test and vestibular evoked myogenic potentials. Assessment will be performed at
baseline and at 1, 2, 4, and 8 weeks post-randomization.
This study is designed as an 8-week, single-center, randomized, assessor- and
analyst-blinded, controlled trial with two parallel interventional groups in a 1:1
allocation.
Patients will be recruited from outpatient clinics of the Eye and ENT Hospital of Fudan
University in Shanghai, qualified with well-trained doctors, staff and required facilities
for this clinical trial.
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