Otitis Media With EffusionNCT00393900
Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion
An observational study of Otitis Media With Effusion, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will determine if the investigators can use certain tests (eustachian tube function tests and gas exchange tests) to predict whether or not a child who had tubes surgically placed in their eardrum because of middle-ear disease will redevelop the disease again after the tubes quit working. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Otitis Media With Effusion
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Oct 2012
- Phase
- Observational
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children 3-6 years old who underwent tympanostomy tube insertion for chronic otitis media with effusion within the 6 weeks prior to study enrollment
Who may be able to join
- 3-6 years old
- History of chronic otitis media with effusion(OME)
- Scheduled or within 6 weeks of tube insertion
- OME at entry or surgery
- Generally good health
Who cannot join
- Cleft palate or other syndromes predisposing to OM
- History of recurrent acute otitis media only
- History of complications of OM or its treatment
- Unable to cooperate for testing
Trial locations and contacts
1 site in 1 country.
United States1 site
ENT Department, Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
This study will determine if the investigators can use certain tests (eustachian tube function tests and gas exchange tests) to predict whether or not a child who had tubes surgically placed in their eardrum because of middle-ear disease will redevelop the disease again after the tubes quit working.
Read the detailed description
This study will enroll children 3-6 years of age with tympanostomy tubes inserted for otitis media with effusion (OME)and measure middle ear gas demand, middle ear volume and eustachian tube function longitudinally between the time of tube insertion and extrusion/nonfunctioning. The data will be used to test the hypotheses that: gas transfer across the middle ear mucosa decreases in phase with resolution of middle ear inflammation and effusion; gas transfer across the middle ear mucosa is increased by an episode of otorrhea; eustachian tube function is unaffected by tympanostomy tube insertion, and measurement of eustachian tube function and trans-middle ear mucosa gas transfer predicts disease recurrence and presentation after tube extrusion/nonfunctioning. The results of these studies will be used to support or refute tested components of existing models of middle ear pressure-regulation and to develop test protocols for risk assignments with respect to disease recurrence in individual ears after tympanostomy tube extrusion/nonfunctioning.
- Conditions
- Otitis Media With Effusion
- Keywords
- otitis media, tympanostomy tube, eustachian tube function, gas exchange, tympanostomy tubes
- Medical subject headings
- Otitis Media with Effusion, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Children with tympanostomy tubes for chronic OME |
What is being measured
The primary outcome is the main question the study is designed to answer.
middle ear status
middle-ear status at 12 months after tympanostomy tube became non-functional
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2006 (estimated)
- Study startAug 2006
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Ellen M. Mandel, University of Pittsburgh
- Investigators
- William J Doyle, PhD, Principal investigator, Department of Otolaryngology, Children's Hospital of PittsburghEllen Mandel, MD, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393900
- Sponsor's protocol ID
- #0605013
- Other IDs
- NIH 1P50DC007667
- Status last verified
- Oct 2017
- First submitted
- 30 Oct 2006
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mandel EM, Swarts JD, Casselbrant ML, Tekely KK, Richert BC, Seroky JT, Doyle WJ. Eustachian tube function as a predictor of the recurrence of middle ear effusion in children. Laryngoscope. 2013 Sep;123(9):2285-90. doi: 10.1002/lary.24021. Epub 2013 Apr 10.
PubMed 23575552
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion
- ClinicalTrials.gov ID
- NCT00393900
- Acronym / sponsor ID
- #0605013
- Conditions
- Otitis Media With Effusion
- Keywords
- otitis media, tympanostomy tube, eustachian tube function, gas exchange, tympanostomy tubes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Aug 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 31 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 will determine if the investigators can use certain tests (eustachian tube function tests and gas exchange tests) to predict whether or not a child who had tubes surgically placed in their eardrum because of middle-ear disease will redevelop the disease again after the tubes quit working.
Detailed description
This study will enroll children 3-6 years of age with tympanostomy tubes inserted for otitis media with effusion (OME)and measure middle ear gas demand, middle ear volume and eustachian tube function longitudinally between the time of tube insertion and extrusion/nonfunctioning. The data will be used to test the hypotheses that: gas transfer across the middle ear mucosa decreases in phase with resolution of middle ear inflammation and effusion; gas transfer across the middle ear mucosa is increased by an episode of otorrhea; eustachian tube function is unaffected by tympanostomy tube insertion, and measurement of eustachian tube function and trans-middle ear mucosa gas transfer predicts disease recurrence and presentation after tube extrusion/nonfunctioning. The results of these studies will be used to support or refute tested components of existing models of middle ear pressure-regulation and to develop test protocols for risk assignments with respect to disease recurrence in individual ears after tympanostomy tube extrusion/nonfunctioning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Children with tympanostomy tubes for chronic OME |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 3-6 years old who underwent tympanostomy tube insertion for chronic otitis media with effusion within the 6 weeks prior to study enrollment
Key inclusion criteria (5 listed)
- 3-6 years old
- History of chronic otitis media with effusion(OME)
- Scheduled or within 6 weeks of tube insertion
- OME at entry or surgery
- Generally good health
Key exclusion criteria (4 listed)
- Cleft palate or other syndromes predisposing to OM
- History of recurrent acute otitis media only
- History of complications of OM or its treatment
- Unable to cooperate for testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
middle ear status
Time frame: 12 months
middle-ear status at 12 months after tympanostomy tube became non-functional
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Results publication: PubMed 23575552Mandel EM, Swarts JD, Casselbrant ML, Tekely KK, Richert BC, Seroky JT, Doyle WJ. Eustachian tube function as a predictor of the recurrence of middle ear effusion in children. Laryngoscope. 2013 Sep;123(9):2285-90. doi: 10.1002/lary.24021. Epub 2013 Apr 10.
- Individual participant dataSharing planned: No
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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.
William J Doyle, PhD principal investigator
Department of Otolaryngology, Children's Hospital of Pittsburgh
Ellen Mandel, MD study director
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media With Effusion, run by University of Pittsburgh 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 5 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: finished, as of the sponsor's last update on 19 Oct 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
middle ear status (time frame: 12 months). 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 NCT00393900, which also lists 1 linked publication.
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 19 Oct 2017.