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The Effect of Early Non-Surgical Treatment of Children With Middle Ear Effusion on the Hearing

Primary Purpose

Secretory Otitis Media, Acute Otitis Media

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Moniri Otovent
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 pressure equalization, middle ear effusion

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Comorbidity,
  • Perforated acute otitis media or other complications of acute otitis media.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Moniri Otovent

    Control

    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. 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.

    No intervention is used in this group.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Change from Baseline in Middle Ear Pressure measured using tympanogram.
    Measuring middle ear pressure using tympanogram.
    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.
    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.

    Full Information

    First Posted
    April 13, 2015
    Last Updated
    November 27, 2016
    Sponsor
    Vastra Gotaland Region
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02549612
    Brief Title
    The Effect of Early Non-Surgical Treatment of Children With Middle Ear Effusion on the Hearing
    Official Title
    The Effect of Early Non-Surgical Treatment of Children With Middle Ear Effusion on the Hearing Level and the Health Economics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2017 (undefined)
    Primary Completion Date
    September 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 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.

    6. Conditions and Keywords

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

    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. 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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No intervention is used in this group.
    Intervention Type
    Device
    Intervention Name(s)
    Moniri Otovent
    Intervention Description
    Please see arm description.
    Primary Outcome Measure Information:
    Title
    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.
    Description
    Measuring hearing threshold using age suitable audiogram.
    Time Frame
    One week after baseline.
    Title
    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.
    Description
    Measuring hearing threshold using age suitable audiogram.
    Time Frame
    One month after baseline.
    Title
    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.
    Description
    Measuring hearing threshold using age suitable audiogram.
    Time Frame
    Three months after baseline.
    Secondary Outcome Measure Information:
    Title
    Change from Baseline in Middle Ear Pressure measured using tympanogram.
    Description
    Measuring middle ear pressure using tympanogram.
    Time Frame
    One week, one month and three months after baseline.
    Title
    Presence of Fluid in the Middle Ear.
    Description
    Microscopic examination of the tympanic membrane to show the presence or absence of fluid in the middle ear.
    Time Frame
    One week, one month and three months after baseline.
    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
    Three months after baseline.
    Title
    Otitis Media Questionnaire-14 (OMQ-14).
    Description
    Please see Links
    Time Frame
    Three months after baseline.
    Title
    Number of Health Care or Hospital Visits due to Ear Associated Problems.
    Time Frame
    Three months after baseline.

    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 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. Exclusion Criteria: Comorbidity, Perforated acute otitis media or other complications of acute otitis media.
    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

    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

    The Effect of Early Non-Surgical Treatment of Children With Middle Ear Effusion on the Hearing

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