Otitis Media With EffusionNCT04395261
Wideband Tympanometry in Otitis Media With Effusion
An observational study of Otitis Media With Effusion, run by Pamukkale University.
Trial summary
The investigators asked the question if they can better estimate the middle ear status in OME that help them to decide between early intervention or longer follow up. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Otitis Media With Effusion
- What is being tested?
- Wideband Tympanometry
- How many people
- 202 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Dec 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: children with otitis media with effusion
Who may be able to join
- All patients were diagnosed by ear examination, pneumatic otoscopy, and type B tympanogram with 226 Hz tympanometry. They were followed for 3 months with proper medication. After 3 months if there was no change with ear examination and 226 Hz tympanometry, surgical ventilation tube insertion was offered.
Who cannot join
- The patients with chronic ear diseases, ototoxic drug use, neurologic disease were excluded.
About this study
Official title: The Differential Diagnosis of Different Middle Ear Fluids in Otitis Media With Effusion by Wideband Tympanometry
The investigators asked the question if they can better estimate the middle ear status in OME that help them to decide between early intervention or longer follow up.
Read the detailed description
Purpose: Otitis media with effusion is an important problem in childhood. After proper diagnosis, generally 3 months of follow up has been recommended before surgical tympanostomy tube insertion. If the physician can estimate the status of the middle ear or fluid type better with a non-invasive method, we can suggest an early operation to these patients or decide to follow up more with no intervention. The purpose of the study is to compare the surgically confirmed middle ear effusions with wideband absorbance values and to differentiate them noninvasively before the operation.
Methods: A total of 123 children that were followed 3 months and treated surgically with the diagnosis of OME were included. Eighty-two sex, age-matched children were tested as control with wideband tympanometry. Ears were divided into four groups according to findings in the operation: serous, mucoid, adhesive, empty. Resonance frequency, 226 Hz, 1000 Hz compliance, Wideband Peak pressure, Absorbance measurements used for comparison.
- Conditions
- Otitis Media With Effusion
- Being tested
- Wideband Tympanometry
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wideband TympanometryDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Group 0 | Patients were divided into groups according to observation in surgery Empty ear in operation Receives: Diagnostic Test: Wideband Tympanometry | |
| Group 1 | Patients were divided into groups according to observation in surgery Serous fluid in operation Receives: Diagnostic Test: Wideband Tympanometry | |
| Group 2 | Patients were divided into groups according to observation in surgery Mucoid fluid in operation Receives: Diagnostic Test: Wideband Tympanometry | |
| Group 3 | Patients were divided into groups according to observation in surgery Adhesive tympanic membrane in operation Receives: Diagnostic Test: Wideband Tympanometry | |
| Group 4 | Control group. Subjects with no otitis media with effusion Receives: Diagnostic Test: Wideband Tympanometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resonance frequency
Wideband resonance frequency was measured
Measured: The same 1 day with the operation
Absorbance
Wideband absorbance of frequencies between 250-8000 Hz were measured
Measured: The same 1 day with the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Jan 2016
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- 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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fazıl Necdet Ardıç, Pamukkale University
- Investigators
- Fazıl N Ardıç, MD, Principal investigator, Chief of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395261
- Sponsor's protocol ID
- 3
- Status last verified
- Sep 2023
- First submitted
- 15 May 2020
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available in the university depository
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Differential Diagnosis of Different Middle Ear Fluids in Otitis Media With Effusion by Wideband Tympanometry
- ClinicalTrials.gov ID
- NCT04395261
- Acronym / sponsor ID
- 3
- Conditions
- Otitis Media With Effusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 20 May 2020 (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.
The investigators asked the question if they can better estimate the middle ear status in OME that help them to decide between early intervention or longer follow up.
Detailed description
Purpose: Otitis media with effusion is an important problem in childhood. After proper diagnosis, generally 3 months of follow up has been recommended before surgical tympanostomy tube insertion. If the physician can estimate the status of the middle ear or fluid type better with a non-invasive method, we can suggest an early operation to these patients or decide to follow up more with no intervention. The purpose of the study is to compare the surgically confirmed middle ear effusions with wideband absorbance values and to differentiate them noninvasively before the operation.
Methods: A total of 123 children that were followed 3 months and treated surgically with the diagnosis of OME were included. Eighty-two sex, age-matched children were tested as control with wideband tympanometry. Ears were divided into four groups according to findings in the operation: serous, mucoid, adhesive, empty. Resonance frequency, 226 Hz, 1000 Hz compliance, Wideband Peak pressure, Absorbance measurements used for comparison.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 0 | – | Diagnostic Test: Wideband TympanometryPatients were divided into groups according to observation in surgery Empty ear in operation |
| Group 1 | – | Diagnostic Test: Wideband TympanometryPatients were divided into groups according to observation in surgery Serous fluid in operation |
| Group 2 | – | Diagnostic Test: Wideband TympanometryPatients were divided into groups according to observation in surgery Mucoid fluid in operation |
| Group 3 | – | Diagnostic Test: Wideband TympanometryPatients were divided into groups according to observation in surgery Adhesive tympanic membrane in operation |
| Group 4 | – | Diagnostic Test: Wideband TympanometryControl group. Subjects with no otitis media with effusion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children with otitis media with effusion
Key inclusion criteria (1 listed)
- All patients were diagnosed by ear examination, pneumatic otoscopy, and type B tympanogram with 226 Hz tympanometry. They were followed for 3 months with proper medication. After 3 months if there was no change with ear examination and 226 Hz tympanometry, surgical ventilation tube insertion was offered.
Key exclusion criteria (1 listed)
- The patients with chronic ear diseases, ototoxic drug use, neurologic disease were excluded.
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 |
|---|---|---|
| Wideband Tympanometry | Diagnostic test | Group 0, Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Resonance frequency
Time frame: The same 1 day with the operation
Wideband resonance frequency was measured
Absorbance
Time frame: The same 1 day with the operation
Wideband absorbance of frequencies between 250-8000 Hz were measured
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 15 Sep 2023.
- Individual participant dataSharing planned: No. Data will be available in the university depository
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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.
Fazıl N Ardıç, MD principal investigator
Chief of Department
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media With Effusion, run by Pamukkale University.
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 1 inclusion and 1 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 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Resonance frequency (time frame: The same 1 day with the operation). 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 15 Sep 2023; AzTrials last refreshed its copy on 26 Oct 2026.