Efficacy of the EarPopper Device in Children With Recurrent Otitis Media

Acute Otitis Media Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03534219
• Other study ID #: 18-0388-LHH
• Status: Withdrawn
• Phase: N/A
• Start date: July 24, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: December 2020
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media
• Recurrent Acute Otitis Media

Intervention

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.

Locations

Country	Name	City	State
United States	Lenox Hill Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (3)

Arick DS, Silman S. Nonsurgical home treatment of middle ear effusion and associated hearing loss in children. Part I: clinical trial. Ear Nose Throat J. 2005 Sep;84(9):567-8, 570-4, 576 passim. Erratum in: Ear Nose Throat J. 2005 Oct;84(10):614. — View Citation

Banigo A, Hunt A, Rourke T, Whiteside O, Aldren C. Does the EarPopper(®) device improve hearing outcomes in children with persistent otitis media with effusion? A randomised single-blinded controlled trial. Clin Otolaryngol. 2016 Feb;41(1):59-65. doi: 10.1111/coa.12480. — View Citation

Silman S, Arick DS, Emmer MB. Nonsurgical home treatment of middle ear effusion and associated hearing loss in children. Part II: Validation study. Ear Nose Throat J. 2005 Oct;84(10):646, 648, 650 passim. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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