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

NCT02546518 | Unknown

• 1 other identifier: Non-Surgical Treatment of SOM
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Secretory Otitis Media

Keywords

Conductive hearing loss; Middle ear effusion; Middle ear pressure equalization

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Hearing Level measured using age suitable audiogram.

  Measuring hearing threshold using age suitable audiogram.

  At time of inclusion, one month, three months and six months after inclusion.

Secondary Outcomes (5)

• Change from Baseline in Middle Ear Pressure measured using tympanogram.

  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.

• The Presence of Fluid in the Middle Ear.

  At time of inclusion, one month, three months and six months after inclusion.

• 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.

  Six months after inclusion.

• Otitis Media Questionnaire-14 (OMQ-14).

  At time of inclusion, three months and six months after inclusion.

• Number of Health Care or Hospital Visits due to Ear Associated Problems.

  Six months after inclusion.

Study Arms (2)

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. 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

Tympanostomy tube in the ear drum

ACTIVE COMPARATOR

Operation for insertion of tympanostomy tube under general anesthesia.

Device: Tympanostomy tube in the ear drum

Interventions

Moniri Otovent DEVICE

Please see Arm Description.

Moniri Otovent

Tympanostomy tube in the ear drum DEVICE

Insertion of tympanostomy tube/Grommet in the ear drums.

Tympanostomy tube in the ear drum

Eligibility Criteria

• Age: 30 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Comorbidity.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

RECRUITING

Related Links

• OMQ-14

MeSH Terms

Conditions

Otitis Media with Effusion; Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Hearing Loss; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hasse Ejnell

  Sahlgrenska University Hospital

  STUDY DIRECTOR

Central Study Contacts

Mohammed Al-Azzawe

CONTACT

mohammed.al-azzawe@vgregion.se

Hasse Ejnell

CONTACT

hasse.ejnell@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2015
• First Posted: September 11, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 29, 2016

Record last verified: 2016-11

Locations

SE (1)