WithdrawnNot Applicable

Efficacy of the EarPopper Device in Children With Recurrent Otitis Media

Stopped: No participants enrolled

United States0Started 2018-07-24

Plain-language summary

This is a randomized controlled clinical trial evaluating the efficacy of the EarPopper device (EP) in the reduction of episodes of acute otitis media (AOM) in children with recurrent otitis media. The control arm will be observational. The intervention arm will have the EP used.

Who can participate

Age range4 Years – 11 Years

SexALL

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Inclusion criteria

✓. Provision of signed and dated informed consent form from parent, plus assent form (if age appropriate)
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Male or female, aged 4-11
✓. Diagnosed with recurrent AOM, defined as: least 2 episodes of AOM within the preceding year of date of screening
✓. Must be able to follow directions to use EarPopper, or have a caregiver able to administer the device.
✓. Patient must be currently free of middle ear effusion or current acute OM. This will be determined on physical examination during screening visit

Exclusion criteria

✕. Patient with chronic middle ear effusion.
✕. Patients with potential complications or confounding conditions: asthma, chronic sinusitis, immunodeficiency, diabetes mellitus
✕. Patient with cleft palate.

What they're measuring

Incidence of AOM

Timeframe: 1 year

Trial details

NCT IDNCT03534219

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-01

View on ClinicalTrials.gov More Recurrent Acute Otitis Media trials