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.
Investigators
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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