NCT03974867

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

Vestibular Prognosis Assessment of the Idiopathic Sudden Sensorineural Hearing Loss With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Vestibular Vertigo
• Sudden Hearing Loss

Interventions

Type	Name	Description
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;

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-07-01
• Completion: 2020-12-01
• First posted: 2019-06-05
• Last updated: 2019-07-24

Locations

1 site across 1 country: China