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Vestibular Prognosis Assessment of ISSNHL With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids

NCT03974867 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2019-07-24

No results posted yet for this study

Summary

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.

Conditions

  • Vestibular Vertigo
  • Sudden Hearing Loss

Interventions

DRUG

Prednisone 5Mg Tab

Glucocorticoids: d1-d7: Oral Pred. 1mg/kg/d a (maximum daily dosage is no more than 60mg); d8-d9: Oral Pred. 10mg less than d7; d10-d11: Oral Pred. 10mg less than d9; d12: Oral Pred. 10mg less than d11; d13: Oral Pred. 10mg less than d12; d14: Oral Pred. 10mg less than d13;

DRUG

Methylprednisolone 40 mg

Glucocorticoids: 7 intratympanic injections of 40mg/ml Met. in 14 days, one injection every other day;

Sponsors & Collaborators

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Huawei Li, MD, PhD · Eye and ENT Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2020-07-31
Completion
2020-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03974867 on ClinicalTrials.gov