Efficacy of the EarPopper Device in Children With Recurrent Otitis Media

Northwell Health

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Conditions

Recurrent Acute Otitis Media Acute Otitis Media

Interventions

EarPopperDEVICE

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.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 11 YearsHealthy volunteers:

Medical Language ↔ Plain English

INCLUSION CRITERIA In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form from parent, plus assent form (if age appropriate) 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 4-11 4. Diagnosed with recurrent AOM, defined as: least 2 episodes of AOM within the preceding year of date of screening 5. Must be able to follow directions to use EarPopper, or have a caregiver able to administer the device. 6. 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 An individual who meets any of the following criteria will be excluded from participation in this study: 1. Patient with chronic middle ear effusion. 2. Patients with potential complications or confounding conditions: asthma, chronic sinusitis, immunodeficiency, diabetes mellitus 3. Patient with cleft palate.

Locations (1)

Lenox Hill Hospital

New York, New York, United States

Outcomes

Primary Outcomes

Incidence of AOM

Null Hypothesis: The incidence of AOM is the same between two arms of the study. Description: Definition of AOM will be presence of AOM documented in the clinic notes during the follow-up period. This is a binary data point. Test: chi-square test with a 0.05 two-sided significance level

Time frame: 1 year

Secondary Outcomes

Hazard ratio of time to AOM

Null hypothesis: Hazard ratios between groups is the same. Test: Cox proportional hazards ratio (CPH) model for time-to-event data will be computed. Actuarial data will be displayed as Kaplan Meier curves (KM) and the differences between the curves will be tested with the Log-rank test. Assumptions for proportional hazards will be conducted to ensure that the data obtained fulfills the criteria for the Cox model.

Time frame: 1 year

Proportion of patients without AOM and antibiotics use

Null hypothesis: Proportion is the same between groups. Test: Fisher exact test will be used to compare the proportions

Time frame: 1 year

Otitis Media Outcome-22 (OMO-22) form and questionnaire

Null hypothesis: Otitis Media Outcome-22 form scores are the same between the two arms of the study. Description: The Otitis Media Outcome-22 form is a 22-item questionnaire based on a 7-point Likert scale. The questionnaire is divided into physical, emotional, hearing loss, speech, and social symptoms subsets. The Likert range is 0-6, 0 being no problem and 6 being the worst. The total score is calculated by adding up all the scores from the 22 individual questions. Therefore, the max possible total score is = (6 for each individual item) \* (22 items) = 132. Range of total score = 0-132. The higher the total score, the worse the impact of otitis media in the patient. Test: Significance testing between timepoints will be performed using paired t test statistics for parametric data with equal distributions and the Mann-Whitney rank sum test for nonparametric data.

Time frame: 1 year

Data from ClinicalTrials.gov

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