Secretory Otitis Media Clinical Trial
Official title:
A Comparison of Surgical and a New Non-Surgical Treatment Methods for Secretory Otitis Media in Children- Hearing and Socioeconomic Aspects
Secretory otitis media (SOM) or middle ear effusion is a common finding affecting children
in the age of 4-5 years. It is usually associated with 5-15 deci Bells hearing loss.
Although spontaneous resolution with normalisation of hearing is the usual outcome, this can
take several months. Secretory otitis media is the most common cause of hearing impairment
in the paediatric age group. When the hearing loss caused by SOM is bilateral and persists
for 3-6 months or more, surgery with tympanostomy tube insertion under general anaesthesia
is indicated. In Sweden, 10000 children undergo this operation annually. Although many
children with unilateral or bilateral SOM improve in the summer, the problem usually recurs
in the autumn or winter. The cost of SOM for the Swedish society was 600 million Swedish
crowns 2005.
In two previous studies, the investigators concluded that the nonsurgical treatment method,
that was developed to assist children with SOM equalising their middle ear pressure, could
normalise the hearing level in 80 % of children with SOM of minimum duration of 3 months.
These children avoided therefore grommet insertion.
The investigators would like to assess the effect of this new treatment method on mainly the
hearing threshold of children with SOM. The investigators expect that using the new method
could help children with SOM avoid operation with grommet insertion.
Background:
SOM or middle ear effusion is the most common cause of hearing impairment in children.
Hearing loss occurs due to the accumulation of fluid in the middle ear. In most of the
cases, SOM follows acute otitis media (AOM). In cases when the SOM is bilateral and persists
for more than 3-6 months, operation with grommet insertion under general anaesthesia is
indicated. 10000 children with SOM are operated with grommet insertion every year in Sweden.
In cases of unilateral hearing loss caused by SOM, grommet insertion is rarely indicated if
the duration of symptoms is less than one year. Some patients develop persistent perforation
in the eardrum after extrusion of the tympanostomy tube.
A new method of middle ear pressure equalisation has been developed at the Sahlgrenska
University Hospital. 45 children in the age of 2-8 years with SOM that persisted for more
than 3 months had been treated with this new method under the waiting period for grommet
insertion. 80% of these children had been cured with regaining of normal hearing and avoided
operation. No complication/side effects were noticed and the compliance was good.
Aim of the study:
The study aims to compare the surgical treatment with the new non surgical treatment of SOM.
The effect of both treatment methods on hearing level and health economics will be assessed.
Hypothesis:
Can hearing improvement be achieved by the new non surgical treatment method of children
with persistent SOM.
Material and Method:
80 children in the age of 2,5-7 years with 3-6 months duration of bilateral SOM associated
with hearing loss and type B or C2 tympanogram will be offered inclusion in the study. All
the patients will undergo during the first visit microscopic examination of the ears,
audiogram and tympanogram. The children will be randomised thereafter into two groups. The
first group is treated with the new method for one month. While the other group is operated
with grommet insertion under general anesthesia. If the waiting time for the operation
exceeds four weeks, the child undergo a new audiogram and tympanogram and if the results are
still abnormal, the operation is performed. The second group will act as a control. Both
groups undergo one month after completed treatment new examination with microscopic
examination of the ears, audiogram for both groups and tympanogram for group one, due to the
fact that tympanogram results are not conclusive in the presence of grommet in the ear drum.
Intervention:
The first group with verified middle ear effusion is treated with the new nonsurgical method
of middle ear pressure equalisation. A face mask is connected to a tube to which a coloured
balloon is attached. The tube is also connected to balloon. A safety valve is used to
prevent too high air pressure. A 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, a low pressure balloon
is used, then it is changed with a higher pressure balloon after one week. Full compliance
for the treatment is defined as 20 blows (5 minutes) in the morning and evening for one
week.
Expected results and importance:
The investigators expect that the study will show that the new treatment method of SOM, can
effectively improve hearing of the affected child. This can be of great significance from
medical, social and economic point of view. Hearing impairment in the paediatric age group
has a great negative impact on speech development and are not only disadvantageous to the
child and the parent but also for the whole society.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT02549612 -
The Effect of Early Non-Surgical Treatment of Children With Middle Ear Effusion on the Hearing
|
N/A |