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A Comparison of Surgical and a New Non-Surgical Treatment Methods for Secretory Otitis Media in Children

Primary Purpose

Secretory Otitis Media

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Moniri Otovent
Tympanostomy tube in the ear drum
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

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

30 Months - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

Moniri Otovent

Tympanostomy tube in the ear drum

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from Baseline in Hearing Level measured using age suitable audiogram.
Measuring hearing threshold using age suitable audiogram.

Secondary Outcome Measures

Change from Baseline in Middle Ear Pressure measured using tympanogram.
Measuring middle ear pressure using tympanogram.
The Presence of Fluid in the Middle Ear.
Microscopic examination of the tympanic membrane to show presence of fluid in the middle ear.
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.
Otitis Media Questionnaire-14 (OMQ-14).
Please see Links
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

Full Information

First Posted
September 6, 2015
Last Updated
November 27, 2016
Sponsor
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT02546518
Brief Title
A Comparison of Surgical and a New Non-Surgical Treatment Methods for Secretory Otitis Media in Children
Official Title
A Comparison of Surgical and a New Non-Surgical Treatment Methods for Secretory Otitis Media in Children- Hearing and Socioeconomic Aspects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secretory Otitis Media
Keywords
Conductive hearing loss, Middle ear effusion, Middle ear pressure equalization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moniri Otovent
Arm Type
Experimental
Arm Description
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.
Arm Title
Tympanostomy tube in the ear drum
Arm Type
Active Comparator
Arm Description
Operation for insertion of tympanostomy tube under general anesthesia.
Intervention Type
Device
Intervention Name(s)
Moniri Otovent
Intervention Description
Please see Arm Description.
Intervention Type
Device
Intervention Name(s)
Tympanostomy tube in the ear drum
Intervention Description
Insertion of tympanostomy tube/Grommet in the ear drums.
Primary Outcome Measure Information:
Title
Change from Baseline in Hearing Level measured using age suitable audiogram.
Description
Measuring hearing threshold using age suitable audiogram.
Time Frame
At time of inclusion, one month, three months and six months after inclusion.
Secondary Outcome Measure Information:
Title
Change from Baseline in Middle Ear Pressure measured using tympanogram.
Description
Measuring middle ear pressure 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.
Title
The Presence of Fluid in the Middle Ear.
Description
Microscopic examination of the tympanic membrane to show presence of fluid in the middle ear.
Time Frame
At time of inclusion, one month, three months and six months after inclusion.
Title
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.
Title
Otitis Media Questionnaire-14 (OMQ-14).
Description
Please see Links
Time Frame
At time of inclusion, three months and six months after inclusion.
Title
Number of Health Care or Hospital Visits due to Ear Associated Problems.
Description
Registration done by the parents of the number of visits to health care center or to hospital due to ear associated troubles
Time Frame
Six months after inclusion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Al-Azzawe
Email
mohammed.al-azzawe@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Hasse Ejnell
Email
hasse.ejnell@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasse Ejnell
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
State/Province
Västra Götaland
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Al-Azzawe, MD
Email
mohammed.al-azzawe@vgregion.se

12. IPD Sharing Statement

Links:
URL
http://www.cmaj.ca/content/suppl/2015/07/27/cmaj.141608.DC1/141608-res-3-at.pdf
Description
OMQ-14

Learn more about this trial

A Comparison of Surgical and a New Non-Surgical Treatment Methods for Secretory Otitis Media in Children

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