Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000619246
Ethics application status
Approved
Date submitted
23/07/2009
Date registered
27/07/2009
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Hyperbaric oxygen for hearing loss and tinnitus
Scientific title
For adults with sudden sensorineural hearing loss, with or without tinnitus, and with an onset within the past 14 days, does the application of hyperbaric oxygen therapy, in addition to the standard therapy of oral steriods, result in an improvement in hearing, tinnitus or quality of life?
Secondary ID [1] 288160 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute, sudden sensorineural hearing loss, with or without tinnitus where no definite cause can be identified. 237348 0
Condition category
Condition code
Ear 239669 239669 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hyperbaric oxygen therapy (HBOT). Daily sessions Monday to Friday for 2 hours at 2.0 ATA (202.6 kPa) while breathing 100% oxygen. Total number of treatments 15 over three consecutive weeks.
Participants will also take the standard medication (see below) starting on the same day as the first hyperbric oxygen session.
Intervention code [1] 237010 0
Treatment: Other
Intervention code [2] 237015 0
Treatment: Drugs
Comparator / control treatment
Prednisone orally, 50 mg daily for ten days and then tailing off by 5 mg per day until no further dose. Total 21 day course.
Participants will recieve a sham hyperbaric exposure involving 15 sessions on the same schedule as the HBOT group, but breathing air. These participants will be compressed to approximately 1.3 atmospheres at the start of each sham session to simulate the 'real' treatment. They will then be slowly returned to 1 ATA for the majority of the session time. The compression to 1.3 atmospheres will then be repeated at the end to simulate decompression.
Control group
Active

Outcomes
Primary outcome [1] 240444 0
Pure tone average threshold (decibels) using standard pure tone audiometry at 500, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hertz.
Timepoint [1] 240444 0
End of HBOT or sham therapy and three months post-therapy.
Secondary outcome [1] 244949 0
Visual analogue scale of tinnitus loudness
Timepoint [1] 244949 0
End of HBOT or sham therapy and three months post-therapy.
Secondary outcome [2] 244950 0
The Modified Amsterdam Inventory for Auditory Disability and Handicap. This is a measure of impact on daily life of hearing loss.
Timepoint [2] 244950 0
End of HBOT or sham therapy and three months post-therapy.

Eligibility
Key inclusion criteria
All adult patients (>18 yrs) presenting with idiopathic sudden sensorineural hearing loss (ISSHL), with or without tinnitus and where the first hyperbaric session can be administered within 14 days of the onset of symptoms. Diagnosis will exclude other causes of sudden hearing loss historically (e.g. Menieur’s disease, barotrauma, noise-induced hearing loss, ototoxic drugs) and by a magnetic resonance image (MRI) of the affected side to exclude an acoustic neuroma or other tumour.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient refusal (HBOT will not be offered to those who refuse to participate),
Contraindications to HBOT including inability to equalise the middle ear or respiratory sinuses, claustrophobia, pneumothorax, previous bleomycin administration or severe respiratory disease with carbon dioxide retention, presence of hearing decrement (documented) for greater than two weeks.

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)
Allocation will be the responsibility of a single central research officer not otherwise involved in the trial or in treatment of patients in any of the participating centres.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation officer will use a random number generating program provided at the ‘research randomiser’ site (http://www.randomizer.org/). We will ensure approximately equal numbers of participants in each treatment group at each participating centre by using a separate randomisation schedule at each centre and permuted blocks. There will be three separate randomisations schedules for mild hearing loss (>10 to 30dB hearing loss at any frequency on pure tone audiometry), moderate hearing loss (>30 to 90dB) and severe hearing loss (>90dB) in order to examine the effect of HBOT at different levels of severity.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/02/2010
Actual
22/02/2010
Date of last participant enrolment
Anticipated
Actual
15/02/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
225
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237394 0
Charities/Societies/Foundations
Name [1] 237394 0
Undersea and Hyperbaric Medical Society (part)
Country [1] 237394 0
United States of America
Primary sponsor type
Individual
Name
Michael Bennett
Address
c/- Dept. of Diving and Hyperbaric Medicine
Level 1, Prince of Wales Hospital
Barker St
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 236893 0
Individual
Name [1] 236893 0
Jan Lehm
Address [1] 236893 0
c/- Dept. of Diving and Hyperbaric Medicine
Level 1, Prince of Wales Hospital
Barker St
Randwick
NSW 2031
Country [1] 236893 0
Australia
Other collaborator category [1] 793 0
Individual
Name [1] 793 0
Tom Kertesz
Address [1] 793 0
c/- Dept. Ear Nose and Throat Surgery
Prince of Wales Hospital,
Barker St
Randwick
NSW 2031
Country [1] 793 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239525 0
South Eastern Sydney Area Health Service, NSW
Ethics committee address [1] 239525 0
Level 1, Edmund Blackett Building
Prince of Wales Hospital
Randwick, NSW 2031
Ethics committee country [1] 239525 0
Australia
Date submitted for ethics approval [1] 239525 0
01/08/2009
Approval date [1] 239525 0
21/11/2009
Ethics approval number [1] 239525 0
HREC2409

Summary
Brief summary
In this study, we aim to show whether hyperbaric oxygen therapy (HBOT) is beneficial for patients with sudden onset of hearing loss (with or without a ringing in the ears) where no cause can be found for the hearing loss.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29961 0
Prof Michael Bennett
Address 29961 0
Dept Diving and Hyperbaric Medicine
Level 1, Prince of Wales Hospital
Randwick, NSW 2031
Country 29961 0
Australia
Phone 29961 0
+61 2 9382 3880
Fax 29961 0
Email 29961 0
[email protected]
Contact person for public queries
Name 13208 0
Prof Michael Bennett
Address 13208 0
c/- Dept. Diving and Hyperbaric Medicine
Level 1, Prince of Wales Hospital
Barker St.
Randwick
NSW 2031
Country 13208 0
Australia
Phone 13208 0
+61 2 9382 3880
Fax 13208 0
Email 13208 0
[email protected]
Contact person for scientific queries
Name 4136 0
Prof Michael Bennett
Address 4136 0
c/- Dept. Diving and Hyperbaric Medicine
Level 1, Prince of Wales Hospital
Barker St.
Randwick
NSW 2031
Country 4136 0
Australia
Phone 4136 0
+61 2 9382 3880
Fax 4136 0
Email 4136 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseThe myopic shift associated with hyperbaric oxygen administration is reduced when using a mask delivery system compared to a hood - a randomised controlled trial.2019https://dx.doi.org/10.28920/dhm49.4.245-252
N.B. These documents automatically identified may not have been verified by the study sponsor.