Secretory Otitis MediaNCT02549612
The Effect of Early Non-Surgical Treatment of Children With Middle Ear Effusion on the Hearing
A study testing Moniri Otovent in people with Secretory Otitis Media and Acute Otitis Media, run by Vastra Gotaland Region.
Trial summary
Secretory otitis media (SOM) or middle ear effusion is a common finding after acute otitis media (AOM). 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, Acute Otitis Media
- What is being tested?
- Moniri Otovent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2017to 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 middle ear effusion with resultant conductive hearing loss one week after acute otitis media.
- Intact tympanic membranes bilaterally.
- Acceptable level of written and spoken swedish language skills.
Who cannot join
- Comorbidity,
- Perforated acute otitis media or other complications of acute otitis media.
Trial locations and contacts
No sites are listed yet.
Mohammed Al-Azzawe contact
Hasse Ejnell contact
About this study
Official title: The Effect of Early Non-Surgical Treatment of Children With Middle Ear Effusion on the Hearing Level and the Health Economics
Secretory otitis media (SOM) or middle ear effusion is a common finding after acute otitis media (AOM). 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 hearing directly after AOM. The investigators expect that using the new method could rapidly normalise hearing in these cases and thereby operation with grommet insertion could be avoided.
Read the detailed description
Background:
Secretory otitis media (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:
To assess the effectivity of the new nonsurgical treatment method for equalisation of middle ear pressure in rapid regaining of hearing after acute otitis media in 2,5-7 years old children.
Study design:
Quantitative
Hypothesis:
Can the new nonsurgical method rapidly normalise hearing in children with middle ear effusion/secretory otitis media after acute otitis media.
Material and Method:
80 children in the age of 2,5-7 years will be offered, directly after completed treatment of AOM, 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 week. While the other group is not actively treated and will act as a control. Both groups undergo one week after randomisation new examination with microscopic examination of the ears, audiogram and tympanogram. These examinations are repeated after one and three months.
Intervention:
The first group with verified middle ear effusion after AOM 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. On the first day, a low pressure balloon is used, then it is changed to a balloon with higher pressure. If no effect is noticed, (the child should experience clicking sound in one or both ears) on the third day, the balloon is replaced with a new balloon with additionally higher pressure. 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 secondary to AOM can rapidly and 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, Acute Otitis Media
- Being tested
- Moniri Otovent
- Keywords
- Conductive hearing loss, middle ear pressure equalization, middle ear effusion
- Medical subject headings
- Otitis Media with Effusion, Otitis Media, 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.
| 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. On the first day, a low pressure balloon is used, then it is changed with a higher pressure balloon. If no effect is noticed, (the child should experience clicking sound in one or both ears) after day 3, the balloon is replaced with a new balloon with additionally higher pressure. Full compliance for the treatment is defined as 20 blows (5 minutes) in the morning and evening for one week. Receives: Device: Moniri Otovent |
| Control | No intervention | No intervention is used in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline (start of treatment in the treatment group or start of control in the control group) in Hearing Level measured using age suitable audiogram.
Measuring hearing threshold using age suitable audiogram.
Measured: One week after baseline.
Change from Baseline (start of treatment in the treatment group or start of control in the control group) in Hearing Level measured using age suitable audiogram.
Measuring hearing threshold using age suitable audiogram.
Measured: One month after baseline.
Change from Baseline (start of treatment in the treatment group or start of control in the control group) in Hearing Level measured using age suitable audiogram.
Measuring hearing threshold using age suitable audiogram.
Measured: Three months after baseline.
Secondary outcomes (5)
Change from Baseline in Middle Ear Pressure measured using tympanogram.
Measuring middle ear pressure using tympanogram.
Measured: One week, one month and three months after baseline.
Presence of Fluid in the Middle Ear.
Microscopic examination of the tympanic membrane to show the presence or absence of fluid in the middle ear.
Measured: One week, one month and three months after baseline.
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: Three months after baseline.
Otitis Media Questionnaire-14 (OMQ-14).
Please see Links
Measured: Three months after baseline.
Number of Health Care or Hospital Visits due to Ear Associated Problems.
Measured: Three months after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startMar 2017
- Primary completionSep 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
- NCT02549612
- Sponsor's protocol ID
- Hearing improvement after AOM
- Status last verified
- Nov 2016
- First submitted
- 13 Apr 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
- The Effect of Early Non-Surgical Treatment of Children With Middle Ear Effusion on the Hearing Level and the Health Economics
- ClinicalTrials.gov ID
- NCT02549612
- Acronym / sponsor ID
- Hearing improvement after AOM
- Conditions
- Secretory Otitis Media, Acute Otitis Media
- Keywords
- Conductive hearing loss, middle ear pressure equalization, middle ear effusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- Mar 2017
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 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 after acute otitis media (AOM). 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 hearing directly after AOM. The investigators expect that using the new method could rapidly normalise hearing in these cases and thereby operation with grommet insertion could be avoided.
Detailed description
Background:
Secretory otitis media (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:
To assess the effectivity of the new nonsurgical treatment method for equalisation of middle ear pressure in rapid regaining of hearing after acute otitis media in 2,5-7 years old children.
Study design:
Quantitative
Hypothesis:
Can the new nonsurgical method rapidly normalise hearing in children with middle ear effusion/secretory otitis media after acute otitis media.
Material and Method:
80 children in the age of 2,5-7 years will be offered, directly after completed treatment of AOM, 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 week. While the other group is not actively treated and will act as a control. Both groups undergo one week after randomisation new examination with microscopic examination of the ears, audiogram and tympanogram. These examinations are repeated after one and three months.
Intervention:
The first group with verified middle ear effusion after AOM 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. On the first day, a low pressure balloon is used, then it is changed to a balloon with higher pressure. If no effect is noticed, (the child should experience clicking sound in one or both ears) on the third day, the balloon is replaced with a new balloon with additionally higher pressure. 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 secondary to AOM can rapidly and 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. On the first day, a low pressure balloon is used, then it is changed with a higher pressure balloon. If no effect is noticed, (the child should experience clicking sound in one or both ears) after day 3, the balloon is replaced with a new balloon with additionally higher pressure. Full compliance for the treatment is defined as 20 blows (5 minutes) in the morning and evening for one week. |
| Control | No intervention | –No intervention is used in this group. |
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 middle ear effusion with resultant conductive hearing loss one week after acute otitis media.
- Intact tympanic membranes bilaterally.
- Acceptable level of written and spoken swedish language skills.
Key exclusion criteria (2 listed)
- Comorbidity,
- Perforated acute otitis media or other complications of acute otitis media.
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 |
Primary outcome
Change from Baseline (start of treatment in the treatment group or start of control in the control group) in Hearing Level measured using age suitable audiogram.
Time frame: One week after baseline.
Measuring hearing threshold using age suitable audiogram.
Change from Baseline (start of treatment in the treatment group or start of control in the control group) in Hearing Level measured using age suitable audiogram.
Time frame: One month after baseline.
Measuring hearing threshold using age suitable audiogram.
Change from Baseline (start of treatment in the treatment group or start of control in the control group) in Hearing Level measured using age suitable audiogram.
Time frame: Three months after baseline.
Measuring hearing threshold using age suitable audiogram.
5 secondary outcomes
Change from Baseline in Middle Ear Pressure measured using tympanogram.
Time frame: One week, one month and three months after baseline.
Presence of Fluid in the Middle Ear.
Time frame: One week, one month and three months after baseline.
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: Three months after baseline.
Otitis Media Questionnaire-14 (OMQ-14).
Time frame: Three months after baseline.
Number of Health Care or Hospital Visits due to Ear Associated Problems.
Time frame: Three months after baseline.
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
Questions about this trial
What is this clinical trial studying?
A study testing Moniri Otovent in people with Secretory Otitis Media and Acute Otitis Media, run by Vastra Gotaland Region.
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 2 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.
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 (start of treatment in the treatment group or start of control in the control group) in Hearing Level measured using age suitable audiogram. (time frame: One week after baseline.). The study lists 3 primary outcomes in all. 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.