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Trial record 30 of 449 for:    OTITIS

Efficacy of the EarPopper Device in Children With Recurrent Otitis Media

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 11, 2018
First Posted Date  ICMJE May 23, 2018
Last Update Posted Date July 26, 2018
Actual Study Start Date  ICMJE July 24, 2018
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2018)
  • 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.
  • 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
  • OMO-22 score and questionnaire [ Time Frame: 1 year ]
    Null hypothesis: OMO-22 outcomes are the same between the two arms of the study. Description: The OMO-22 is a questionnaire that has a (a) continuous scale measurement component and (b) likert type ordinal scale data Test: Tests will be performed on the outcomes of the modified OMO-22 instrument. Significance testing between times will be performed using paired t test statistics for parametric data with equal distributions and the Mann-Whitney rank sum test for nonparametric data.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of the EarPopper Device in Children With Recurrent Otitis Media
Official Title  ICMJE Efficacy of the EarPopper Device in Children With Recurrent Otitis Media: A Randomized Controlled Trial
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Recurrent Acute Otitis Media
  • Acute Otitis Media
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.

    Intervention: Device: EarPopper
  • 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.

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 11, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lauren Rahman, MHA 2124342262 lrahman2@northwell.edu
Contact: Tristan Tham, MD 2124343643 ttham@northwell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03534219
Other Study ID Numbers  ICMJE 18-0388-LHH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Sharing plan is currently undecided
Responsible Party Tristan Tham, Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tristan Tham, MD Lenox Hill Hospital
PRS Account Northwell Health
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP