Efficacy of the EarPopper Device in Children With Recurrent Otitis Media

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Recurrent Acute Otitis Media, Acute Otitis Media

Intervention / Treatment
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* Device: EarPopper


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA 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 EXCLUSION CRITERIA 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All subjects will be randomized in a 1:1 ratio using permuted blocks. Subjects will be stratified by site (Lenox Hill) prior to randomization.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm: EarPopper<br>All patients in this arm will receive the EarPopper device. Length of administration: 1 year Dose: Dosing of the EP device will be twice per day, once in the morning and once before bedtime. This is consistent with previous dosing which showed no adverse events and an excellent safety profile. 5, 6 Administration: Hold nosepiece firmly against nostril opening creating a good, tight seal is crucial. Plug the other nostril closed. Push button to start the airflow and swallow while the device is running. Repeat on other nostril. After 5 minutes, repeat steps 1 - 3. This will complete one treatment. Telephone call survey: Will be administered monthly by study investigator. Telephone call survey is based on the OMO-22 Form. | Device: EarPopper<br>* 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.<br>|
| No Intervention: Control<br>All patients in this arm will not receive any intervention. EarPopper device will be given to this group at the end of follow-up period (1 year) Telephone call survey: Will be administered monthly by study investigator. Telephone call survey is based on the OMO-22 Form. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Earpopper, Prophylaxis, Randomized controlled trial