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Efficacy of the EarPopper Device in Children With Recurrent Otitis Media

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ClinicalTrials.gov Identifier: NCT03534219
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Tristan Tham, Northwell Health

Brief 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.

Condition or disease Intervention/treatment Phase
Recurrent Acute Otitis Media Acute Otitis Media Device: EarPopper Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Masking Description: Since there will be no dummy devices in this trial, we will be unable to blind the patients and physicians to whom is using the EP device. The assessors/data collectors will be blinded for patient follow-up, and the statistician will be blinded. Therefore this will be a double blinded study.
Primary Purpose: Prevention
Official Title: Efficacy of the EarPopper Device in Children With Recurrent Otitis Media: A Randomized Controlled Trial
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Experimental: Intervention Arm: EarPopper

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:

  1. Hold nosepiece firmly against nostril opening creating a good, tight seal is crucial. Plug the other nostril closed.
  2. Push button to start the airflow and swallow while the device is running.
  3. 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
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.

No Intervention: Control

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.




Primary Outcome Measures :
  1. Incidence of AOM [ Time Frame: 1 year ]

    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



Secondary Outcome Measures :
  1. Hazard ratio of time to AOM [ Time Frame: 1 year ]
    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.

  2. Proportion of patients without AOM and antibiotics use [ Time Frame: 1 year ]
    Null hypothesis: Proportion is the same between groups. Test: Fisher exact test will be used to compare the proportions

  3. Otitis Media Outcome-22 (OMO-22) form and questionnaire [ Time Frame: 1 year ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534219


Contacts
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Contact: Lauren Rahman, MHA 2124342262 lrahman2@northwell.edu
Contact: Tristan Tham, MD 2124343643 ttham@northwell.edu

Locations
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United States, New York
Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact: Lauren Rahman, MHA    212-434-2262    lrahman2@northwell.edu   
Sub-Investigator: Peter Costantino, MD         
Principal Investigator: Daniel Arick, MD         
Sub-Investigator: Lauren Rahman, MHA         
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Tristan Tham, MD Lenox Hill Hospital

Publications:
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Responsible Party: Tristan Tham, Research Scientist, Northwell Health
ClinicalTrials.gov Identifier: NCT03534219     History of Changes
Other Study ID Numbers: 18-0388-LHH
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Sharing plan is currently undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Tristan Tham, Northwell Health:
Earpopper
Prophylaxis
Randomized controlled trial
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases