Recurrent Acute Otitis MediaNCT03534219
Efficacy of the EarPopper Device in Children With Recurrent Otitis Media
A study testing EarPopper in people with Recurrent Acute Otitis Media and Acute Otitis Media, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Acute Otitis Media, Acute Otitis Media
- What is being tested?
- EarPopper
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2018to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the EarPopper Device in Children With Recurrent Otitis Media: A Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Recurrent Acute Otitis Media, Acute Otitis Media
- Being tested
- EarPopper
- Keywords
- Earpopper, Prophylaxis, Randomized controlled trial
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
Hazard ratio of time to AOM
Null hypothesis: Hazard ratios between groups is the same. Test: Cox proportional hazards ratio (CPH) model for time-to-event data will be computed. Actuarial data will be displayed as Kaplan Meier curves (KM) and the differences between the curves will be tested with the Log-rank test. Assumptions for proportional hazards will be conducted to ensure that the data obtained fulfills the criteria for the Cox model.
Measured: 1 year
Proportion of patients without AOM and antibiotics use
Null hypothesis: Proportion is the same between groups. Test: Fisher exact test will be used to compare the proportions
Measured: 1 year
Otitis Media Outcome-22 (OMO-22) form and questionnaire
Null hypothesis: Otitis Media Outcome-22 form scores are the same between the two arms of the study.
Description: The Otitis Media Outcome-22 form is a 22-item questionnaire based on a 7-point Likert scale. The questionnaire is divided into physical, emotional, hearing loss, speech, and social symptoms subsets. The Likert range is 0-6, 0 being no problem and 6 being the worst.
The total score is calculated by adding up all the scores from the 22 individual questions. Therefore, the max possible total score is = (6 for each individual item) * (22 items) = 132. Range of total score = 0-132. The higher the total score, the worse the impact of otitis media in the patient.
Test: Significance testing between timepoints will be performed using paired t test statistics for parametric data with equal distributions and the Mann-Whitney rank sum test for nonparametric data.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start24 Jul 2018
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Recurrent Acute Otitis MediaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tristan Tham, Northwell Health
- Investigators
- Tristan Tham, MD, Principal investigator, Lenox Hill Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534219
- Sponsor's protocol ID
- 18-0388-LHH
- Status last verified
- Dec 2020
- First submitted
- 11 May 2018
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Sharing plan is currently undecided
Publications
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.
PubMed 16261757Silman 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.
PubMed 16382747Banigo 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.
PubMed 26095773
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the EarPopper Device in Children With Recurrent Otitis Media: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03534219
- Acronym / sponsor ID
- 18-0388-LHH
- Conditions
- Recurrent Acute Otitis Media, Acute Otitis Media
- Keywords
- Earpopper, Prophylaxis, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: EarPopper | Experimental | Device: EarPopperAll 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. |
| 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. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EarPopperThe 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. | Device | Intervention Arm: EarPopper |
Primary outcome
Incidence of AOM
Time frame: 1 year
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
3 secondary outcomes
Hazard ratio of time to AOM
Time frame: 1 year
Proportion of patients without AOM and antibiotics use
Time frame: 1 year
Otitis Media Outcome-22 (OMO-22) form and questionnaire
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Background: PubMed 16261757Arick 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.
- Background: PubMed 16382747Silman 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.
- Background: PubMed 26095773Banigo 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.
- Individual participant dataSharing planned: Undecided. Sharing plan is currently undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tristan Tham, MD principal investigator
Lenox Hill Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EarPopper in people with Recurrent Acute Otitis Media and Acute Otitis Media, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AOM (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03534219, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.