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

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ClinicalTrials.gov Identifier: NCT02549612
Recruitment Status : Unknown
Verified November 2016 by Vastra Gotaland Region.
Recruitment status was:  Not yet recruiting
First Posted : September 15, 2015
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

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.


Condition or disease Intervention/treatment Phase
Secretory Otitis Media Acute Otitis Media Device: Moniri Otovent Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Early Non-Surgical Treatment of Children With Middle Ear Effusion on the Hearing Level and the Health Economics
Study Start Date : March 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Experimental: Moniri Otovent
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.
Device: Moniri Otovent
Please see arm description.

No Intervention: Control
No intervention is used in this group.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Change from Baseline in Middle Ear Pressure measured using tympanogram. [ Time Frame: One week, one month and three months after baseline. ]
    Measuring middle ear pressure using tympanogram.

  2. Presence of Fluid in the Middle Ear. [ Time Frame: One week, one month and three months after baseline. ]
    Microscopic examination of the tympanic membrane to show the presence or absence of fluid in the middle ear.

  3. 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. ]
  4. Otitis Media Questionnaire-14 (OMQ-14). [ Time Frame: Three months after baseline. ]
    Please see Links

  5. Number of Health Care or Hospital Visits due to Ear Associated Problems. [ Time Frame: Three months after baseline. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549612


Contacts
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Contact: Mohammed Al-Azzawe mohammed.al-azzawe@vgregion.se
Contact: Hasse Ejnell hasse.ejnell@vgregion.se

Sponsors and Collaborators
Vastra Gotaland Region
Investigators
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Study Director: Hasse Ejnell Sahlgrenska University Hospital, Sweden

Additional Information:
OMQ-14  This link exits the ClinicalTrials.gov site

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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT02549612     History of Changes
Other Study ID Numbers: Hearing improvement after AOM
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016

Keywords provided by Vastra Gotaland Region:
Conductive hearing loss
middle ear pressure equalization
middle ear effusion

Additional relevant MeSH terms:
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Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases