Efficacy of the EarPopper Device in Children With Recurrent Otitis Media

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

Sponsors

Lead Sponsor: Northwell Health

Source 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.

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).

Overall Status Withdrawn
Start Date 2018-07-24
Completion Date 2021-01-01
Primary Completion Date 2020-12-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of AOM 1 year
Secondary Outcome
Measure Time Frame
Hazard ratio of time to AOM 1 year
Proportion of patients without AOM and antibiotics use 1 year
Otitis Media Outcome-22 (OMO-22) form and questionnaire 1 year
Condition
Intervention

Intervention Type: Device

Intervention Name: EarPopper

Description: 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.

Arm Group Label: Intervention Arm: EarPopper

Eligibility

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.

Gender:

All

Minimum Age:

4 Years

Maximum Age:

11 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Tristan Tham, MD Principal Investigator Lenox Hill Hospital
Location
Facility: Lenox Hill Hospital
Location Countries

United States

Verification Date

2020-12-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Northwell Health

Investigator Full Name: Tristan Tham

Investigator Title: Research Scientist

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Intervention Arm: EarPopper

Type: Experimental

Description: 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.

Label: Control

Type: No Intervention

Description: 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.

Patient Data Undecided
Study Design Info

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.

Primary Purpose: Prevention

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.

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