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

NCT02549612 | Unknown

• 1 other identifier: Hearing improvement after AOM
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Secretory Otitis Media; Acute Otitis Media

Keywords

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

Outcome Measures

Primary Outcomes (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.

  Measuring hearing threshold using age suitable audiogram.

  One week after baseline.

• 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.

  One month after baseline.

• 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.

  Three months after baseline.

Secondary Outcomes (5)

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

  One week, one month and three months after baseline.

• Presence of Fluid in the Middle Ear.

  One week, one month and three months after baseline.

• 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.

  Three months after baseline.

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

  Three months after baseline.

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

  Three months after baseline.

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. 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

Control

NO INTERVENTION

No intervention is used in this group.

Interventions

Moniri Otovent DEVICE

Please see arm description.

Moniri Otovent

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Related Links

• OMQ-14

MeSH Terms

Conditions

Otitis Media with Effusion; Otitis Media; Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

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: April 13, 2015
• First Posted: September 15, 2015
• Study Start: March 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 29, 2016

Record last verified: 2016-11