INFLATE Trial


What is the INFLATE Trial?

“Nasal Balloon Auto-inflation for Aboriginal & Torres Strait Islander Children with Otitis Media with Effusion.”

(testing a novel treatment for glue ear)


What is otitis media with effusion and what is the INFLATE Trial about?

Otitis media with effusion (OME) or ’glue ear’ is a common ear problem in children. In OME, fluid builds up in the middle ear instead of draining away like it should to the back of the throat. Aboriginal and Torres Strait Islander children get OME more often than non-Aboriginal children. It is the most common cause of hearing loss and reason for surgery in children. OME can be detected during routine screening, after ear infections or just by chance when a child is seen for some other reason. This is one of the conditions we look for on the Aboriginal health checks and school screenings.

According to current standard practice, children with OME are monitored for 3 months. If OME persists, the child is referred to an ENT surgeon to consider grommet (ventilation tube) surgery to help drain the fluid.

Overseas studies show the use of nasal balloon auto-inflation may help treat OME. Autoinflation is where a child inflates a balloon with their nostrils, using a small plastic device. This opens up the Eustachian tube and helps middle ear fluid drain naturally away.  If the fluid is drained, the hearing should return to normal.

Studies show nasal balloon auto-inflation does not usually cause any complications. Some children occasionally say it is uncomfortable. Nasal balloon auto-inflation has not been studied in Aboriginal and Torres Strait Islander children, though is commonly used in some other countries.

The goal of this INFLATE Trial is to see if nasal balloon auto-inflation is effective in treating OME in Aboriginal and Torres Strait Islander children aged 3-16 years.  Improved OME management will help Aboriginal and Torres Strait Islander children have healthy ears and reduce hearing loss.

What will happen in the INFLATE Trial?

Six Aboriginal Community Controlled Health Services or Indigenous health services in Queensland, NSW and Victoria are partners in the INFLATE trial.

Local Research Officers at each of the sites will help recruit approximately 380 children with OME. A computer program will randomly allocate children to one of two groups;

  1. Standard Care: This is usual clinical care.  Carers are educated about looking after their child’s hearing and ears.
  2. 'Otovent’™ Nasal Balloon Auto-inflation: the child with OME is taught to inflate a balloon device (Otovent™) through each nostril 2 – 3 times a day.

All the children in the study will have regular check-ups and referral to an ENT surgeon if the OME persists. Children in both groups will also have a hearing test at 3 months if the OME has not settled.

Other INFLATE outcomes:
  • We will be checking the value for money of using Otovent or usual care for OME. This will take into account things like the health of the child and the time and money carers spend looking after their child.
  • We will also study how carers, Aboriginal health workers, doctors, researchers and others feel about research and how the study worked to make sure that our research meets the needs of Aboriginal and Torres Strait Islander communities.

How will INFLATE benefit Aboriginal and Torres Strait Islander people?

Hearing loss, such as that caused by OME, may result in problems with learning at school and difficulties getting a job later in life. We hope that this study will provide evidence to guide management of OME in Aboriginal and Torres Strait Islander children which may also apply more widely.

If you would like any further information about this research please contact Dr Penny Abbott (E: p.abbott@westernsydney.edu.au M: 0414 645 062).