Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001495112p
Ethics application status
Not yet submitted
Date submitted
16/10/2019
Date registered
29/10/2019
Date last updated
29/10/2019
Date data sharing statement initially provided
29/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial comparing conventional steroid treatment to conventional steroids plus hyperbaric oxygen treatment in sudden sensorineural hearing loss within two weeks of onset.
Scientific title
The Effectiveness of Steroids and Hyperbaric oxygen for sudden sensorineural hearing loss (SHOOSH): a randomised controlled trial.
Secondary ID [1] 299571 0
Nil known
Universal Trial Number (UTN)
U1111-1242-1577
Trial acronym
SHOOSH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sudden idiopathic sensorineural hearing loss 314843 0
Condition category
Condition code
Ear 313180 313180 0 0
Deafness
Neurological 313265 313265 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hyperbaric oxygen treatment (100% oxygen via hood or face mask for 85 mins in a compressed chamber) daily at 2.4 ATA for 20 days with a 5 min air break after 20 mins at depth. Administered in accordance with the Australian and New Zealand Standard (ASNZ 4774.2) by a qualified specialist in hyperbaric medicine. Patients have daily attendance as a hospital outpatient attendance recorded in their medical record.
Intervention code [1] 315826 0
Treatment: Other
Comparator / control treatment
Control group is conventional oral steroid treatment for two weeks as recommended by the American Academy of Otolarngology and Head and Neck Surgeons clinical practice guideline.
Oral methylprednisolone 50 mg daily for 7 days then 25 mg for 7 days.
Control group
Active

Outcomes
Primary outcome [1] 321697 0
Hearing change as measured on comparison of audiograms at the end of treatment
Timepoint [1] 321697 0
Baseline then 10 days ,20 days (primary endpoint) and 6 months post commencement of treatment
Secondary outcome [1] 375937 0
We propose to use the Euro-Qual questionnaire EQ5D (this requires HREC approval which is pending)
Timepoint [1] 375937 0
20 days and 6 months post intervention commencement

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes or web based depending on funding
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation via software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Multicentre
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size is currently being calculated from a pilot study utilising variability in speech discrimination scores in patients who receive HBOT for a power of 80% and p<0.05.
Once the sample size is known the groups will be compared using a biostatistician from another institution (QIMR Berghoffer) using standard statistical packages (SAS) for two tail testing at significance levels of 0.05 for hearing threshold differences and speech discrimination scoring. Quality of life scores will be analysed by non parametric permutation testing.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2020
Actual
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
29/07/2022
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,WA,VIC
Recruitment hospital [1] 14993 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 14994 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [3] 14995 0
The Townsville Hospital - Douglas
Recruitment hospital [4] 14996 0
The Alfred - Melbourne
Recruitment hospital [5] 14997 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [6] 14998 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 28278 0
2031 - Randwick
Recruitment postcode(s) [2] 28279 0
6150 - Murdoch
Recruitment postcode(s) [3] 28280 0
4814 - Douglas
Recruitment postcode(s) [4] 28281 0
3004 - Melbourne
Recruitment postcode(s) [5] 28282 0
4029 - Herston
Recruitment postcode(s) [6] 28283 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 304055 0
Self funded/Unfunded
Name [1] 304055 0
Country [1] 304055 0
Primary sponsor type
University
Name
University of Queensland
Address
Office of Sponsored Research, Cumbrae-Stewart Building #72, The University of Queensland Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 304248 0
Hospital
Name [1] 304248 0
Royal Brisbane and Women's Hospital
Address [1] 304248 0
Butterfield St
Herston
QLD 4920
Country [1] 304248 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304547 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 304547 0
Butterfield St
Herston
Qld 4920
Ethics committee country [1] 304547 0
Australia
Date submitted for ethics approval [1] 304547 0
01/01/2020
Approval date [1] 304547 0
Ethics approval number [1] 304547 0

Summary
Brief summary
This trial is to determine the efficacy of HBOT in addition to steroids in the treatment of ISSHL against conventional steroids alone. There has been increasing evidence of efficacy and a recent Cochrane review suggested a large well designed RCT is needed to understand the role of HBOT. There are wide differences in clinical management across Australia due to the lack of evidence of which strategy is best. This trial hopes to bring clarity to the best management in terms of hearing outcomes.
Trial website
Trial related presentations / publications


Public notes

Contacts
Principal investigator
Name 97338 0
Dr Susannah Sherlock
Address 97338 0
Royal Brisbane and Womens Hospital
Butterfield St
Herston
QLD 4029
Country 97338 0
Australia
Phone 97338 0
+61 0736460241
Fax 97338 0
610736460747
Email 97338 0
[email protected]
Contact person for public queries
Name 97339 0
Dr Susannah Sherlock
Address 97339 0
Royal Brisbane and Womens Hospital
Butterfield St
Herston
QLD
4029
Country 97339 0
Australia
Phone 97339 0
+61 0736460241
Fax 97339 0
610736460747
Email 97339 0
[email protected]
Contact person for scientific queries
Name 97340 0
Dr Susannah Sherlock
Address 97340 0
Royal Brisbane and Womens Hospital
Butterfield St
Herston
QLD
4029
Country 97340 0
Australia
Phone 97340 0
+61 0736460241
Fax 97340 0
610736460747
Email 97340 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de identified tabulated data in published results only. Raw (deidentified) line by line data for all individuals will be available for institutional, personal or editorial review by request.


The sample size required is being calculated from another study and 100 patients is at this point only a guide.
When will data be available (start and end dates)?
Immediately following Publication date until 36 months post publication.
Available to whom?
Anyone who can access published trials and researchers requesting the deidentified data on case by case basis.
Available for what types of analyses?
Meta analyses
How or where can data be obtained?
From principal author Dr Susannah Sherlock
([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5358Study protocol    378570-(Uploaded-16-10-2019-18-48-32)-Study-related document.docx
5359Informed consent form    378570-(Uploaded-16-10-2019-18-51-20)-Study-related document.doc



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.