None listed
Conditions
Brief summary
We aim to establish the usability and effectiveness of a new insufflation device, as a way to open the Eustachain Tube and drain the middle ear fluid in children with chronic otitis media with effusion (OME).
Interventions
In a single session, lasting approximately 15 minutes in total, the investigator will assist the child in using an eustachian tube insufflation device that creates controlled nasal pressurisation during swallowing with up to 10 pressurisations.
The Eustachian tube insufflation device is in the form of a sippy cup that a young child can drink from, but with a nasal interface connected to an automated pressurisation element. When the child is drinking from the bottle and align their nose correctl
In a single session, lasting approximately 15 minutes in total, the investigator will assist the child in using an eustachian tube insufflation device that creates controlled nasal pressurisation during swallowing with up to 10 pressurisations. The Eustachian tube insufflation device is in the form of a sippy cup that a young child can drink from, but with a nasal interface connected to an automated pressurisation element. When the child is drinking from the bottle and align their nose correctly over the air hole on the device, air pressure is applied in the nasal cavity. This pressurisation of the nasal cavity can open the Eustachian tube and reduce negative middle ear pressure. Investigator will observe the child to see whether they are using the device correctly, through assessment of successful drinking from the cup and correct alignment of the nose on the nasal area on the device. The investigator may need to help the child align their mouth and nose correctly at the beginning to teach the child how to use the device. The purpose-built app connected to the device will record the nasal pressure and number of successful pressurisations while the child drinks approximately 300 mL from the sippy cup. The investigator will record incorrect use of the device and assist the child in using the device correctly. Whether assistance is required will also be recorded.
Sponsors
Curtin University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
• Full understanding of the protocol and signed informed consent by the legal guardian • Able to drink from the bottle appropriately without fear of the device. • Parent English speaking • Type C tympanogram
Exclusion criteria
• Nasal congestion • VPI (Velo-palatal incompetence/velopharyngeal insufficiency) • A history aspiration or known swallowing dysfunction • The presence of craniofacial abnormalities • Other contraindications for positive nasal pressurization • Active acute respiratory infection • Active acute otitis media
Outcome results
None listed