Otitis media with effusion (OME) Ear, Nose and Throat Chronic mucoid otitis media
Conditions
Interventions
Autoinflation
Autoinflation is performed using a purpose manufactured device (Otovent®) as supplied to the trial by Kestrel Medical Ltd. Poole, Dorset. One standard pack contains the nasal tip- a safe
Sponsors
University of Southampton (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 4-11 years and attending school at the time of the first planned tympanometric screen (To be able to reliably perform the technique and have a greater theoretical chance of cure) 2. A relevant notes recorded history of recent and/or recurrent otitis media symptoms (defined as within the last year) or ear related problems in the previous year (e.g. suspected hearing loss, slow speech development etc), or a guardian denotes a concern in one or more OME related symptom domains on the screening invitation letter symptom check list (in the targeted 4 to 7 years of age and seasonal high risk of OME groups) 3. Tympanometric confirmation in a child of at least one B tympanogram (using the modified Jerger classification). This has an approximate 90% positive predictive value of an effusion being present i.e. cases of unilateral or bilateral OME.
Exclusion criteria
Exclusion criteria: 1. Children who need early referral as judged clinically, to include those known rarer cases with high risk of recurrence: Down's syndrome, cleft palate, kartagener's syndrome, primary ciliary dyskinesia, immunodeficiency states, etc. 2. Four year old children not attending school at the time of screening, or children deemed by the nurse unable to comply with the technique of autoinflation 3. At study entry, children with a grommet already in place in an ear drum, or where the child has been referred or listed for ear surgery 4. Latex allergy (balloons are latex) 5. A recent nose bleed in the past three weeks or more than one episode of nose bleeding over the past 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Tympanometric resolution in at least one affected ear per child at 1 month, defined as conversion of the B-type highly predictive of effusion to either an A1 or C1 type i.e. back to normal pressures 2. In addition, study specific questionnaire at baseline, 1 and 3 months, weekly diaries up to 3 months (to record days with reported hearing loss and earache and also include less documented adverse events e.g. vertigo, as well as recording periods of remission and recurrence) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tympanometric resolution in at least one affected ear per child at 3 months, defined as conversion of the B-type highly predictive of effusion to either an A1 or C1 type i.e. back to normal pressures 2. OMQ-14a functional health status measure, Health Utilities Index, study specific questionnaire of NHS resource use - all self-administered at baseline and 3 months, plus a study specific questionnaire on health resource use including recurrence, referral etc at 6 months. 3. Short study-specific questionnaires at baseline, 1 and 3 months to evaluate compliance, positives/negatives of device. Record of nurse assessments at 1 and 3 months. | — |
Countries
United Kingdom
Outcome results
None listed