Efficacy of the EarPopper Device in Children With Recurrent Otitis Media
Withdrawn before enrolling · Not applicable
Conditions studied: Recurrent Acute Otitis Media, Acute Otitis Media
In brief
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.
Key facts
- Study ID
- NCT03534219
- Run by
- Northwell Health
- People needed
- 0
- Starts
- 2018-07-24
- Expected to finish
- 2021-01-01
- Last updated by the study team
- 2020-12-23
Who can join
Age: 4 and older, up to 11. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- In order to be eligible to participate in this study, an individual must meet all of the following 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
You may not qualify if…
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Patient with chronic middle ear effusion.
- Patients with potential complications or confounding conditions: asthma, chronic sinusitis, immunodeficiency, diabetes mellitus
- Patient with cleft palate.
Where it is running
- Lenox Hill Hospital — New York, New York, United States
Full record on ClinicalTrials.gov
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