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

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ClinicalTrials.gov Identifier: NCT02546518
Recruitment Status : Unknown
Verified November 2016 by Vastra Gotaland Region.
Recruitment status was:  Recruiting
First Posted : September 11, 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 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.


Condition or disease Intervention/treatment Phase
Secretory Otitis Media Device: Moniri Otovent Device: Tympanostomy tube in the ear drum 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: A Comparison of Surgical and a New Non-Surgical Treatment Methods for Secretory Otitis Media in Children- Hearing and Socioeconomic Aspects
Study Start Date : September 2015
Estimated Primary Completion Date : April 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. 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.
Device: Moniri Otovent
Please see Arm Description.

Active Comparator: Tympanostomy tube in the ear drum
Operation for insertion of tympanostomy tube under general anesthesia.
Device: Tympanostomy tube in the ear drum
Insertion of tympanostomy tube/Grommet in the ear drums.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
    Measuring middle ear pressure using tympanogram.

  2. The Presence of Fluid in the Middle Ear. [ Time Frame: At time of inclusion, one month, three months and six months after inclusion. ]
    Microscopic examination of the tympanic membrane to show presence 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: Six months after inclusion. ]
  4. Otitis Media Questionnaire-14 (OMQ-14). [ Time Frame: At time of inclusion, three months and six months after inclusion. ]
    Please see Links

  5. Number of Health Care or Hospital Visits due to Ear Associated Problems. [ Time Frame: Six months after inclusion. ]
    Registration done by the parents of the number of visits to health care center or to hospital due to ear associated troubles



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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 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.

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): NCT02546518


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

Locations
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Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Västra Götaland, Sweden
Contact: Mohammed Al-Azzawe, MD       mohammed.al-azzawe@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: NCT02546518     History of Changes
Other Study ID Numbers: Non-Surgical Treatment of SOM
First Posted: September 11, 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 effusion
Middle ear pressure equalization

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