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Clinical Trials/ACTRN12622001555741
ACTRN12622001555741
Recruiting
Phase 4

A double-blinded randomized controlled clinical trial to examine the hearing outcome of intratympanic dexamethasone injection compared with placebo control in subjects who experienced a sudden onset of sensorineural hearing loss

niversity of Melbourne0 sites200 target enrollmentDecember 16, 2022

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Idiopathic Sudden Sensorineural Hearing Loss
Sponsor
niversity of Melbourne
Enrollment
200
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 16, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Melbourne

Eligibility Criteria

Inclusion Criteria

  • 1\. Idiopathic sudden sensorineural hearing loss (ISSNHL) defined as a history of a sudden decrease in hearing; not exceeding seven days in duration.
  • 2\. A sensorineural hearing loss demonstrable on a pure\-tone audiogram at the time of entry into the trial (a 20 dB or more hearing loss in at least three frequencies compared to the healthy ear).
  • 3\. No otological pathological history or examination findings.
  • 4\. Absence of other neurological signs except the eighth cranial nerve defect.

Exclusion Criteria

  • 1\. All other types of sensorineural hearing loss, or conductive forms of hearing impairment.
  • 2\. A history of fluctuating sensorineural hearing loss.
  • 3\. Medical conditions rendering prescription of steroids unsafe. For example, patients with hypertension, diabetes, active peptic disease, pregnancy, chronic infections, uncompensated heart disease, recent surgery or psychiatric disease.

Outcomes

Primary Outcomes

Not specified

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