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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
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
Secondary ID [1] 308487 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Sudden Sensorineural Hearing Loss 328300 0
Condition category
Condition code
Ear 325350 325350 0 0
Deafness

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 324926 0
Treatment: Drugs
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.
Control group
Placebo

Outcomes
Primary outcome [1] 333208 0
Change in pure-tone hearing thresholds as measured by manual pure-tone audiometry.
Timepoint [1] 333208 0
- Baseline
- 2-3 weeks after 1st injection
- 4-5 weeks after 2nd injection
Secondary outcome [1] 416174 0
Change in perceived tinnitus using the Tinnitus Handicap Inventory
Timepoint [1] 416174 0
- Baseline
- 2-3 weeks after 1st injections
- 4-5 weeks after 2nd injection

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/01/2023
Actual
28/02/2023
Date of last participant enrolment
Anticipated
30/12/2024
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
200
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23691 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 39126 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 312732 0
Charities/Societies/Foundations
Name [1] 312732 0
Passe & Williams Foundation
Country [1] 312732 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville, VIC 3010
Country
Australia
Secondary sponsor category [1] 314351 0
None
Name [1] 314351 0
N/A
Address [1] 314351 0
N/A
Country [1] 314351 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312028 0
Royal Victorian Eye and Ear Hospital Human Research Ethics Committee
Ethics committee address [1] 312028 0
32 Gisborne Street, East Melbourne VIC 3002
Ethics committee country [1] 312028 0
Australia
Date submitted for ethics approval [1] 312028 0
19/07/2022
Approval date [1] 312028 0
26/07/2022
Ethics approval number [1] 312028 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123230 0
Dr Benjamin Wei
Address 123230 0
Department of Otolaryngology, University of Melbourne,
Level 5, Royal Victorian Eye and Ear Hospital,
32 Gisborne Street, East Melbourne VIC 3002
Country 123230 0
Australia
Phone 123230 0
+61 3 9116 5800
Fax 123230 0
Email 123230 0
bjnwei@hotmail.com
Contact person for public queries
Name 123231 0
Ms Amelia Darke
Address 123231 0
Department of Otolaryngology, University of Melbourne,
Level 5, Royal Victorian Eye and Ear Hospital,
32 Gisborne Street, East Melbourne VIC 3002
Country 123231 0
Australia
Phone 123231 0
+61 3 9929 8293
Fax 123231 0
Email 123231 0
amelia.darke@unimelb.edu.au
Contact person for scientific queries
Name 123232 0
Dr Benjamin Wei
Address 123232 0
Department of Otolaryngology, University of Melbourne,
Level 5, Royal Victorian Eye and Ear Hospital,
32 Gisborne Street, East Melbourne VIC 3002
Country 123232 0
Australia
Phone 123232 0
+61 3 9116 5800
Fax 123232 0
Email 123232 0
bjnwei@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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


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.