ACTRN12622001555741RecruitingPhase 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 enrollmentStarted: December 16, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
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.
Investigators
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