Clinical trial NCT03534219: Efficacy of the EarPopper Device in Children With Recurrent Otitis Media
Official title: Efficacy of the EarPopper Device in Children With Recurrent Otitis Media: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Recurrent Acute Otitis Media
Acute Otitis Media
Keywords: Earpopper
Prophylaxis
Randomized controlled trial
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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).

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.

Primary outcomes:
measure: Incidence of AOM
timeFrame: 1 year
Secondary outcomes:
measure: Hazard ratio of time to AOM
timeFrame: 1 year
measure: Proportion of patients without AOM and antibiotics use
timeFrame: 1 year
measure: Otitis Media Outcome-22 (OMO-22) form and questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
Study officials:
affiliation: Lenox Hill Hospital
name: Tristan Tham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.