Efficacy of the EarPopper Device in Children With Recurrent Otitis Media

Northwell Health

Status: Withdrawn

Conditions: Acute Otitis Media; Recurrent Acute Otitis Media

Treatments: Device: EarPopper

Study type: Interventional

Funder types: Other

Identifiers

NCT03534219

18-0388-LHH

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 4 to 11 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Intervention Arm: EarPopper

Experimental group

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: 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.

Treatment:

Device: EarPopper

Control

No Intervention group

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.