Otitis MediaPhase 4NCT00393159
The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
A Phase 4 study testing Ear Popper in people with Otitis Media and Conductive Hearing Loss, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This study is designed to check the effect of the use of the ear popper device on serous otitis media in children and on the conductive hearing loss accompanying the otitis. It is intended that 30 children aged 3-18 years will participate in the study. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Otitis Media, Conductive Hearing Loss
- What is being tested?
- Ear Popper
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2006to not given
- Phase
- Phase 4
- 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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Serous Otitis Media for More Then 3 months
- Conductive Hearing Loss of More Then 15 decibels.
- Tympanometry type B or C.
Who cannot join
- No History of Tympanostomy Tube Insertion or Adenoidectomy
- No Cranio or Facial Malformations
- No Acute Upper Respiratory Tract Infection or Acute Otitis Media
Trial locations and contacts
1 site in 1 country.
Ari DeRowe, MD contact
Israel1 site, 1 recruiting
- Recruiting
ENT Unit, Dana Children's Hospital, Tel-Aviv Medical Center
Tel Aviv
Yael Oestreicher, MD, 972-3-6974517, dkyo@barak-online.net.il
Yael Oestreicher, MD
About this study
This study is designed to check the effect of the use of the ear popper device on serous otitis media in children and on the conductive hearing loss accompanying the otitis. It is intended that 30 children aged 3-18 years will participate in the study. The inclusion criteria are : clinical serous otitis media for a duration of more then 3 months, a conductive hearing loss of at least 15 decibels air bone gap and tympanometry type B or C. The children will use the ear popper for 7 weeks. They will undergo otologic examination, audiometry and tympanometry at the beginning ao the trial, at 7 weeks and at 3 months from the beginning of the trial. The otologic findings and the audiometry and tympanometry results before and after the trial will be compared. We will try to determine whether the use of the ear popper in the test group will improve the conductive hearing loss and prevent the need for tympanostomy tube insertion.
- Conditions
- Otitis Media, Conductive Hearing Loss
- Being tested
- Ear Popper
- Keywords
- Effusion, Otitis, Media, Ear, Popper, Children
- Medical subject headings
- Otitis Media, Hearing Loss, Conductive, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ear PopperDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Audiometry and tympanometry test results at at 7 weeks and 3 months from beginning of use of the ear popper.
Otoscopic findings at at 7 weeks and 3 months from beginning of use of the ear popper.
Secondary outcomes (2)
Hearing improvement at 7 weeks and 3 months from the beginning of the trial.
Rate of referrals for tympanostomy tube insertion at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Yael Oestreicher, MD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393159
- Sponsor's protocol ID
- TASMC06YO3567CTIL
- Status last verified
- Oct 2006
- First submitted
- 24 Oct 2006
- Last updated
- 26 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
- ClinicalTrials.gov ID
- NCT00393159
- Acronym / sponsor ID
- TASMC06YO3567CTIL
- Conditions
- Otitis Media, Conductive Hearing Loss
- Keywords
- Effusion, Otitis, Media, Ear, Popper, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Oct 2006
- First posted
- 26 Oct 2006 (estimated)
- 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 study is designed to check the effect of the use of the ear popper device on serous otitis media in children and on the conductive hearing loss accompanying the otitis. It is intended that 30 children aged 3-18 years will participate in the study. The inclusion criteria are : clinical serous otitis media for a duration of more then 3 months, a conductive hearing loss of at least 15 decibels air bone gap and tympanometry type B or C. The children will use the ear popper for 7 weeks. They will undergo otologic examination, audiometry and tympanometry at the beginning ao the trial, at 7 weeks and at 3 months from the beginning of the trial. The otologic findings and the audiometry and tympanometry results before and after the trial will be compared. We will try to determine whether the use of the ear popper in the test group will improve the conductive hearing loss and prevent the need for tympanostomy tube insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Serous Otitis Media for More Then 3 months
- Conductive Hearing Loss of More Then 15 decibels.
- Tympanometry type B or C.
Key exclusion criteria (3 listed)
- No History of Tympanostomy Tube Insertion or Adenoidectomy
- No Cranio or Facial Malformations
- No Acute Upper Respiratory Tract Infection or Acute Otitis Media
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 |
|---|---|---|
| Ear Popper | Device | – |
Primary outcome
Audiometry and tympanometry test results at at 7 weeks and 3 months from beginning of use of the ear popper.
Otoscopic findings at at 7 weeks and 3 months from beginning of use of the ear popper.
2 secondary outcomes
Hearing improvement at 7 weeks and 3 months from the beginning of the trial.
Rate of referrals for tympanostomy tube insertion at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2006.
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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.
Ari DeRowe, MD contact
Yael Oestreicher, MD principal investigator
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ear Popper in people with Otitis Media and Conductive Hearing Loss, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Oct 2006. 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 Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yael Oestreicher, MD (972-3-6974517, dkyo@barak-online.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Audiometry and tympanometry test results at at 7 weeks and 3 months from beginning of use of the ear popper.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2006.