NCT03534219

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 24, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

December 23, 2020

Status Verified

December 1, 2020

Enrollment Period

2.4 years

First QC Date

May 11, 2018

Last Update Submit

December 21, 2020

Conditions

Recurrent Acute Otitis MediaAcute Otitis Media

Keywords

EarpopperProphylaxisRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

Intervention Arm: EarPopper

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

EarPopperDEVICE

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.

Intervention Arm: EarPopper

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Related 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.

    PMID: 16261757BACKGROUND

  • 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.

    PMID: 16382747BACKGROUND

  • Banigo A, Hunt A, Rourke T, Whiteside O, Aldren C. Does the EarPopper((R)) 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.

    PMID: 26095773BACKGROUND

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Tristan Tham, MD

    Lenox Hill Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: All subjects will be randomized in a 1:1 ratio using permuted blocks. Subjects will be stratified by site (Lenox Hill) prior to randomization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 23, 2018

Study Start

July 24, 2018

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

December 23, 2020

Record last verified: 2020-12

Locations

US(1)