RecruitingACTRN12621000949886

A non-invasive treatment for Otitis Media with Effusion

Usability trial of a non-invasive treatment for Otitis Media with Effusion

Sponsor

Curtin University

Enrollment

25 participants

Start Date

Jul 14, 2021

Study Type

Interventional

Conditions

otitis media with effusion (OME)

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).

Eligibility

Sex: Both males and femalesMin Age: 2 YearssMax Age: 12 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new non-surgical device to treat glue ear (otitis media with effusion, or OME) in young children. Glue ear is a very common childhood condition where fluid becomes trapped behind the eardrum, causing temporary hearing loss. In most cases it resolves on its own, but in persistent cases, children often require a surgical procedure called grommet insertion. The device being tested uses gentle air pressure through a specially designed drinking bottle to open the Eustachian tube — the canal that drains the middle ear — and allow the trapped fluid to drain naturally. This is a usability and effectiveness study to see whether children can use the device comfortably and whether it successfully drains the fluid. Researchers will confirm fluid is present using a tympanogram test before enrollment and will monitor outcomes after treatment. To be eligible, the child must be aged 2 to 12, have a confirmed Type C tympanogram (indicating fluid in the middle ear), be able to drink from a bottle without fear of the device, and have a parent who speaks English. Children with nasal congestion, swallowing problems, craniofacial abnormalities, or an active ear infection are not eligible. This study is run by Curtin University.

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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 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.

Locations(1)

California, United States of America

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ACTRN12621000949886