Secretory Otitis MediaNCT02546518
A Comparison of Surgical and a New Non-Surgical Treatment Methods for Secretory Otitis Media in Children
A study testing Moniri Otovent and Tympanostomy tube in the ear drum in people with Secretory Otitis Media, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 months to 7 years
- Conditions the study is for
- Secretory Otitis Media
- What is being tested?
- Moniri Otovent and Tympanostomy tube in the ear drum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Comorbidity.
Trial locations and contacts
1 site in 1 country.
Mohammed Al-Azzawe contact
Hasse Ejnell contact
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County
Mohammed Al-Azzawe, MD, mohammed.al-azzawe@vgregion.se
About this study
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.
Read the detailed description
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.
- Conditions
- Secretory Otitis Media
- Being tested
- Moniri Otovent, Tympanostomy tube in the ear drum
- Keywords
- Conductive hearing loss, Middle ear effusion, Middle ear pressure equalization
- Medical subject headings
- Otitis Media with Effusion, Hearing Loss, Conductive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moniri OtoventDevice
Please see Arm Description.
Tympanostomy tube in the ear drumDevice
Insertion of tympanostomy tube/Grommet in the ear drums.
| Study group | Role | What they receive |
|---|---|---|
| Moniri Otovent | Experimental | 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. Receives: Device: Moniri Otovent |
| Tympanostomy tube in the ear drum | Active comparator | Operation for insertion of tympanostomy tube under general anesthesia. Receives: Device: Tympanostomy tube in the ear drum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Hearing Level measured using age suitable audiogram.
Measuring hearing threshold using age suitable audiogram.
Measured: At time of inclusion, one month, three months and six months after inclusion.
Secondary outcomes (5)
Change from Baseline in Middle Ear Pressure measured using tympanogram.
Measuring middle ear pressure using tympanogram.
Measured: At time of inclusion, one month, three months and six months after inclusion for the interventional group. At time of inclusion for the control group due to the fact that tympanogram is of no convenience in the presence of tympanostomy tube in the ear.
The Presence of Fluid in the Middle Ear.
Microscopic examination of the tympanic membrane to show presence of fluid in the middle ear.
Measured: At time of inclusion, one month, three months and six months after inclusion.
Health economics measured mainly by the number of parental leave days which the parent/parents needed to take in order to look after the child.
Measured: Six months after inclusion.
Otitis Media Questionnaire-14 (OMQ-14).
Please see Links
Measured: At time of inclusion, three months and six months after inclusion.
Number of Health Care or Hospital Visits due to Ear Associated Problems.
Registration done by the parents of the number of visits to health care center or to hospital due to ear associated troubles
Measured: Six months after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secretory Otitis MediaStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hasse Ejnell, Study director, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546518
- Sponsor's protocol ID
- Non-Surgical Treatment of SOM
- Status last verified
- Nov 2016
- First submitted
- 6 Sep 2015
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Surgical and a New Non-Surgical Treatment Methods for Secretory Otitis Media in Children- Hearing and Socioeconomic Aspects
- ClinicalTrials.gov ID
- NCT02546518
- Acronym / sponsor ID
- Non-Surgical Treatment of SOM
- Conditions
- Secretory Otitis Media
- Keywords
- Conductive hearing loss, Middle ear effusion, Middle ear pressure equalization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- Sep 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moniri Otovent | Experimental | Device: Moniri OtoventA 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. |
| Tympanostomy tube in the ear drum | Active comparator | Device: Tympanostomy tube in the ear drumOperation for insertion of tympanostomy tube under general anesthesia. |
Who may qualify
- Ages
- 30 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Comorbidity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moniri OtoventPlease see Arm Description. | Device | Moniri Otovent |
| Tympanostomy tube in the ear drumInsertion of tympanostomy tube/Grommet in the ear drums. | Device | Tympanostomy tube in the ear drum |
Primary outcome
Change from Baseline in Hearing Level measured using age suitable audiogram.
Time frame: At time of inclusion, one month, three months and six months after inclusion.
Measuring hearing threshold using age suitable audiogram.
5 secondary outcomes
Change from Baseline in Middle Ear Pressure measured using tympanogram.
Time frame: At time of inclusion, one month, three months and six months after inclusion for the interventional group. At time of inclusion for the control group due to the fact that tympanogram is of no convenience in the presence of tympanostomy tube in the ear.
The Presence of Fluid in the Middle Ear.
Time frame: At time of inclusion, one month, three months and six months after inclusion.
Health economics measured mainly by the number of parental leave days which the parent/parents needed to take in order to look after the child.
Time frame: Six months after inclusion.
Otitis Media Questionnaire-14 (OMQ-14).
Time frame: At time of inclusion, three months and six months after inclusion.
Number of Health Care or Hospital Visits due to Ear Associated Problems.
Time frame: Six months after inclusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Al-Azzawe contact
Hasse Ejnell contact
Hasse Ejnell study director
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moniri Otovent and Tympanostomy tube in the ear drum in people with Secretory Otitis Media, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Al-Azzawe (mohammed.al-azzawe@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Hearing Level measured using age suitable audiogram. (time frame: At time of inclusion, one month, three months and six months after inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.