A non-invasive treatment for Otitis Media with Effusio
Not Applicable
Recruiting
- Conditions
- otitis media with effusion (OME)Ear - Other ear disorders
- Registration Number
- ACTRN12621000949886
- Lead Sponsor
- Curtin University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tympanogram assessment: Tympanogram assessment will be conducted before and after each treatment session to detect any change in the middle ear pressure to confirm if the eustachian tubes have been successfully opened and ear pressure equilibrium has been restored.[Immediately after treatment]
- Secondary Outcome Measures
Name Time Method Otoscopic evaluation: If the patient has a middle ear effusion (observed through routine examination with an otoscope) before the treatment session, the otoscopic evaluation will be used to determine whether after using the device the effusion has been removed.[Immediately after treatment]