Efficacy of the EarPopper Device in Children With Recurrent Otitis Media

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

The hypothesis of this randomized controlled trial is that the EP device will be able to prophylactically decrease incidence of AOM in children with recurrent AOM. The secondary hypothesis is that the EP device will be able to decrease morbidity of AOM and severity of AOM in children with recurrent AOM (by measuring quality of life and associated endpoints). The EP device is 510(K) regulated (510(K) Number K073401) as a non-surgical, non-drug related treatment for middle ear pressure problems such as: Middle ear fluid (Otitis Media with Effusion), Eustachian Tube Dysfunction, Temporary hearing loss, Ear pain and pressure caused by air travel, Ear fullness caused by colds, allergies and sinusitis. This is a randomized, controlled, double blinded study. 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. Patients will be followed up for a period of one year, and monthly telephone call interviews will be conducted. All patients will receive the EarPopper device for participation in this trial (for the control arm, they will receive the device at the end of their study follow up). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03534219
Study type	Interventional
Source	Northwell Health
Contact
Status	Withdrawn
Phase	N/A
Start date	July 24, 2018
Completion date	January 1, 2021

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