Efficacy of the EarPopper Device in Children With Recurrent Otitis Media
NCT ID: NCT03534219
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-07-24
2021-01-01
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Intervention Arm: EarPopper
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.
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.
Control
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion 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
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.
4 Years
11 Years
ALL
Yes
Sponsors
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Northwell Health
OTHER
Responsible Party
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Tristan Tham
Research Scientist
Principal Investigators
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Tristan Tham, MD
Role: PRINCIPAL_INVESTIGATOR
Lenox Hill Hospital
Locations
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Lenox Hill Hospital
New York, New York, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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18-0388-LHH
Identifier Type: -
Identifier Source: org_study_id