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Trial registered on ANZCTR
Registration number
ACTRN12622001555741
Ethics application status
Approved
Date submitted
8/12/2022
Date registered
16/12/2022
Date last updated
1/12/2023
Date data sharing statement initially provided
16/12/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Intratympanic Corticosteroid Therapy for Idiopathic Sudden Sensorineural Hearing Loss
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Scientific title
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
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Secondary ID [1]
308487
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Sudden Sensorineural Hearing Loss
328300
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Condition category
Condition code
Ear
325350
325350
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0
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Deafness
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will be randomised into one of two groups:
A) Receives intratympanic (IT) injection of 24mg/ml dexamethasone to the effected ear within 14 days onset of hearing loss, followed by a placebo injection 14 to 21 days after the initial injection.
B) Receives placebo IT injection within 14 days of onset of hearing loss, followed by an IT injection of 24mg/ml dexamethasone 14 to 21 days after initial injection.
All IT injections will be administered by an ENT surgeon within Royal Victorian Eye and Ear clinics.
Participants in both groups will be prescribed a course of oral prednisolone tablets as standard treatment in addition to the IT injections. The duration of the oral prednisolone is 14 days for all participants. A dosage of 1mg per kg of bodyweight per day (with 75mg as the maximum daily dose) will be administered for the first 7 days, followed by tapering of the dosage for a further 7 days.
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Intervention code [1]
324926
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Treatment: Drugs
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Comparator / control treatment
Due to the cross-over design of the trial, all study participants will receive the placebo as either their first or second intratympanic injection. The placebo intratympanic injection is made up of normal saline.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Change in pure-tone hearing thresholds as measured by manual pure-tone audiometry.
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Assessment method [1]
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Timepoint [1]
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- Baseline
- 2-3 weeks after 1st injection
- 4-5 weeks after 2nd injection
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Secondary outcome [1]
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Change in perceived tinnitus using the Tinnitus Handicap Inventory
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Assessment method [1]
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Timepoint [1]
416174
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- Baseline
- 2-3 weeks after 1st injections
- 4-5 weeks after 2nd injection
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
2/01/2023
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Actual
28/02/2023
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Date of last participant enrolment
Anticipated
30/12/2024
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Actual
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Date of last data collection
Anticipated
28/02/2025
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Actual
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Sample size
Target
200
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Accrual to date
25
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
23691
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The Royal Victorian Eye and Ear Hospital - East Melbourne
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Recruitment postcode(s) [1]
39126
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3002 - East Melbourne
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Passe & Williams Foundation
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Address [1]
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Suite 2.06, 517 Flinders Lane, Melbourne VIC 3000 Australia
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Melbourne
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Address
Parkville, VIC 3010
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Country
Australia
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Secondary sponsor category [1]
314351
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None
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Name [1]
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N/A
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Address [1]
314351
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N/A
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Country [1]
314351
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Royal Victorian Eye and Ear Hospital Human Research Ethics Committee
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Ethics committee address [1]
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32 Gisborne Street, East Melbourne VIC 3002
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Ethics committee country [1]
312028
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Australia
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Date submitted for ethics approval [1]
312028
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19/07/2022
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Approval date [1]
312028
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26/07/2022
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Ethics approval number [1]
312028
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Summary
Brief summary
The project will investigate the efficacy of intratympanic injections of dexamethasone in combatting Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL). This is a prospective, cross-over, double blinded randomised controlled trial. Patients presenting to the Emergency Department with ISSNHL and who meet the eligibility criteria will receive two intratympanic (IT) injections to the effected ear - one within the first 14 days of hearing loss onset, and the other 14 to 21 days later. The first injection will contain either 24mg/ml of dexamethasone or a placebo, and the second injection will be the opposite of the first injection. It is hoped that the IT dexamethasone injection will improve the patient's hearing in the effected ear. All patients involved will be prescribed a course of the oral corticosteroid prednisolone as part of standard care in addition to the IT injections. The primary aim is to determine if 24mg/ml IT dexamethasone in the treatment of ISSNHL will improve hearing. Hearing tests and questionnaires will be administered prior to each IT injection to assess the patient's hearing and to evaluate if the timing of the dexamethasone injection has an impact on hearing recovery.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Benjamin Wei
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Address
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Department of Otolaryngology, University of Melbourne,
Level 5, Royal Victorian Eye and Ear Hospital,
32 Gisborne Street, East Melbourne VIC 3002
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Country
123230
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Australia
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Phone
123230
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+61 3 9116 5800
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Fax
123230
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Email
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[email protected]
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Contact person for public queries
Name
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Amelia Darke
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Address
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Department of Otolaryngology, University of Melbourne,
Level 5, Royal Victorian Eye and Ear Hospital,
32 Gisborne Street, East Melbourne VIC 3002
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Country
123231
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Australia
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Phone
123231
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+61 3 9929 8293
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Fax
123231
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Email
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[email protected]
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Contact person for scientific queries
Name
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Benjamin Wei
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Address
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Department of Otolaryngology, University of Melbourne,
Level 5, Royal Victorian Eye and Ear Hospital,
32 Gisborne Street, East Melbourne VIC 3002
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Country
123232
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Australia
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Phone
123232
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+61 3 9116 5800
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Fax
123232
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Email
123232
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Individual participant data will not be shared as it is to remain only accessible by study team members for any future analysis/research
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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