A Comparison of Surgical and a New Non-Surgical Treatment Methods for Secretory Otitis Media in Children
Secretory Otitis Media
About this trial
This is an interventional treatment trial for Secretory Otitis Media focused on measuring Conductive hearing loss, Middle ear effusion, Middle ear pressure equalization
Eligibility Criteria
Inclusion Criteria:
- Unilateral or bilateral secretory otitis media of 3 months duration or more
- Intact tympanic membrane bilaterally.
- Acceptable level of written and spoken swedish language skills.
Exclusion Criteria:
- Comorbidity.
Sites / Locations
- Sahlgrenska University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Moniri Otovent
Tympanostomy tube in the ear drum
A face mask is connected to a tube to which a coloured balloon is attached. The tube is also connected to ambu bag balloon. A safety valve is used to prevent too high air pressure. The ambu bag balloon is hidden in a green soft toy in the form of frog. The parent and the child hold the face mask against the mouth and the child blows the balloon. On need, mainly in the beginning of treatment course, the parent presses the frog's abdomen in order to fill the balloon with air. During the first week day, a low pressure balloon is used, then it is changed with a higher pressure balloon. Full compliance for the treatment is defined as 20 blows (5 minutes) in the morning and evening for one month.
Operation for insertion of tympanostomy tube under general anesthesia.