Autoinflation: Alternative in the Treatment of Otitis Media With Effusion (OME)
Otitis Media With Effusion, Hearing Loss
About this trial
This is an interventional treatment trial for Otitis Media With Effusion
Eligibility Criteria
- Inclusion criteria: Children between 3 and 8 years of age with otomicroscopic alterations suggestive of unilateral or bilateral OME; type B or C2 tympanogram (pressure ≤ 200 daPa); audiogram with hearing loss ≥ 20 dB or air-bone gap at the time of evaluation by an otolaryngologist.
- Exclusion criteria: Children with uncontrolled asthma, craniofacial anomalies, active ear disease (retraction pouch, adhesive otitis or tympanic perforation) or a history of ear surgery.
Sites / Locations
- Centro Hospitalar Univrsitário do PortoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Active Comparator
Treatment with placebo device
Treatment with a working device
Surgical treatment
Device similar to the one developed, but which does not generate pressure
Treatment with a functioning device, which generates the necessary pressure to open the Eustachian tube
Surgical treatment (myringotomy with placement of ventilation tubes) which is the treatment currently applied in children with otitis media with effusion that do not resolve with medical treatment and/or autoinflation