NCT03534219

Efficacy of the EarPopper Device in Children With Recurrent Otitis Media

Efficacy of the EarPopper Device in Children With Recurrent Otitis Media: A Randomized Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 4 Years – 11 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Recurrent Acute Otitis Media
• Acute Otitis Media

Interventions

Type	Name	Description
DEVICE	EarPopper	The EP device is 510(K) regulated (510(K) Number K073401) as a non-surgical, non-drug related treatment for middle ear pressure problems. The device is based on the Politzer Maneuver, and works by opening the Eustachian tube by delivering a safe, constant stream of air into the nasal cavity. In clinical studies funded by the National Institutes of Health (Grant#: 5R44DC003613-03), the EarPopper has proven to be effective in reducing chronic middle ear effusions. By regularly aerating the middle ear, we hypothesize that the EarPopper device will be an effective prophylactic measure to reduce incidence of AOM in children with recurrent OM. The device delivers a jet of air pressure from the nozzle at 5.2PSI, at a volume velocity of 1,524mL/min.

Timeline

• Start date: 2018-07-24
• Primary completion: 2020-12-01
• Completion: 2021-01-01
• First posted: 2018-05-23
• Last updated: 2020-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study