INTERIM REPORT FOR ROUND TWO GRANTS #2
A randomised controlled trial of hyperbaric oxygen for sudden sensorineural hearing loss (ISSNHL)
INTRODUCTIONThe aim of this trial is to settle once and for all the benefit (if any) of hyperbaric oxygen therapy for this important cause of hearing loss. The previous research has been restricted to case reports, case series and five small RCTs. All of the latter have chosen different ways to measure the outcome and so both a lack of statistical power and confusion about the importance of the outcomes have hampered interpretation of these trials to date.
Our research effort is aimed at fixing this situation by performing a study of high methodological rigour and powered sufficiently in order to confirm or refute a clinically important improvement with HBOT. The very welcome grant from the AHDMRT has allowed us to get this study off the ground by funding sufficient patients to complete the `proof of concept trial of 20 patients in each group. This 'pilot' study will then move smoothly into the full study (to enrol 225 patients in total). We will actively seek full funding from the NHMRC and other such bodies based on our progress with your 'seed funding'
Achievements1. We have completed all ethics approval paperwork and had the study formally approved
by the lead ethics committee at South Eastern Sydney Area Health Service.
2. We have assurances from four other centres of their intention to apply for approval in
their own jurisdictions. So far I do not have information on progress at these centres,
but we are scheduled for a teleconference on March l5th to confirm that progress.
These centres are The Wesley Centre for Hyperbaric Medicine, The Royal Brisbane
Hyperbaric Unit, Royal Hobart Hyperbaric Unit and Fremantle Hyperbaric Unit.
3. We are in discussion with Dr. Peter Germonpre in Belgium where they have been
working on a similar study and they have expressed a desire to dovetail into our study
rather than pursue their own. Similarly, the Medical Director and CEO of the Diving
Diseases Research Centre in Plymouth UK, (Dr. Christine Cridge), have expressed a
desire to join us. I will keep you posted on developments. Both these centres have the potential to be large contributors of patients.
4. At POWH we have enrolled our first three patients in the study and two of these have
completed their treatment course to date. There have been no problems with following
the protocol with these first patients, so we remain very confident with our procedures
and look forward to a steady increase in numbers.
Assoc Professor M. Bennett
4 March 2011