Randomised controlled trial comparing conventional steroid treatment to conventional steroids plus hyperbaric oxygen treatment in sudden sensorineural hearing loss within two weeks of onset.
Phase 2
- Conditions
- Sudden idiopathic sensorineural hearing lossEar - DeafnessNeurological - Other neurological disorders
- Registration Number
- ACTRN12619001495112
- Lead Sponsor
- niversity of Queensland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1.Documented diagnosis of ISSHL as defined by the criteria of NIDOCD.
2.Presentation within two weeks of onset of symptoms.
3.Adult aged 18 or over.
4.Normal hearing in contralateral ear.
5.Exclusion of retro-cochlear mass.
6.No contraindication to oral steroids.
7.Fitness for compression in a HBOT chamber.
Exclusion Criteria
1.Contraindication to HBOT as assessed by a hyperbaric physician.
2.Unstable Type 1 diabetes.
3.Other causative agent for hearing loss suspected (e.g. drugs, acoustic trauma).
4.History of middle ear surgery which in the ENT surgeon’s opinion would exclude the patient from being able to be pressurized.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method