Otitis Media EffusionNCT06523933
Distribution of Bacteria in OME After Radiotherapy For NPC.
An observational study of Otitis Media Effusion and Nasopharyngeal Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
To observe the prognostic difference of tympanocentesis in different kinds of otitis media effusion. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Otitis Media Effusion, Nasopharyngeal Carcinoma
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2024to 12 May 2025
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with OME and OME after radiotherapy for NPC, who are given the treatment of tympanostomy only, including outpatient and inpatient patients, were included in the study.
Who may be able to join
- patients clinical diagnosis of OME or OME after radiotherapy for NPC (Diagnostic criteria: fluid visible in the middle ear and a type B tympanogram).
- patients volunteered to participate in the study and signed the informed consent
Who cannot join
- NPC recurrence or other malignant tumor after radiotherapy.
- clear diagnosis of Eustachian ostium atresia or nasal obstruction diseases, such as severe deviated nasal septum, choanal atresia, osteoradionecrosis of skull base after radiotherapy, etc.
- pregnant and lactating women.
- patients with severe underlying diseases or with severe liver and kidney dysfunction.
- patients who could not cooperate (including poor hearing and radiation encephalopathy)
- patients with other middle ear diseases, such as middle ear cholesteatoma, osteoradionecrosis of temporal bone after radiotherapy, etc.
- severe deglutition disorders
- cleft palate
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
About this study
Official title: Distribution of Bacteria in Otitis Media With Effusion After Radiotherapy For Nasopharyngeal Carcinoma.
To observe the prognostic difference of tympanocentesis in different kinds of otitis media effusion.
Read the detailed description
This study is a prospective, observational clinical study to observe the difference in prognosis of tympanocentesis in different kinds of otitis media effusion (OME), especially OME after radiotherapy for nasopharyngeal carcinoma (NPC). A total of 234 patients diagnosed with OME who are given the treatment of tympanocentesis only, including outpatient and inpatient patients, were included in the study. The middle ear effusion collected during the tympanocentesis is sent for bacterial culture. The positive rate of the effusion and the recurrence rate within 24 weeks will be compared in order to figure out whether bacterial infection is an important influencing factor for some kinds of OME in addition to eustachian tube dysfunction, which is acknowledged.
- Conditions
- Otitis Media Effusion, Nasopharyngeal Carcinoma
- Keywords
- Otitis Media Effusion, Nasopharyngeal Carcinoma, Bacteria
- Medical subject headings
- Otitis Media with Effusion, Nasopharyngeal Carcinoma
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 |
|---|---|---|
| ON+ | Patients with OME after NPC with a Positive Result of Bacteria Culture of Middle Ear Effusion. | |
| ON- | Patients with OME after NPC with a Negative Result of Bacteria Culture of Middle Ear Effusion. | |
| O+ | Patients with OME with a Positive Result of Bacteria Culture of Middle Ear Effusion. | |
| O- | Patients with OME with a Negative Result of Bacteria Culture of Middle Ear Effusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Bacterial Culture Rate in Middle Ear Effusion
Measured: Up to 24 weeks
Secondary outcomes (2)
Changes in Air Pressure (Tympanogram)
Tympanogram changed from type B to type A or type C.
Measured: Collected at 6, 12, 24 Weeks after Tympanocentesis
Eustachian Tube Dysfunction Questionnaire (ETDQ-7)
The ETDQ-7 tool is used to assess the symptoms of Otitis Media With Effusion (OME), which consists of seven items with a scale of graduated responses ranging from 1 (No Problem) to 7 (Severe Problem), and 4 would correspond to a Moderate Problem. If the total score is more than 14, it is considered that there is eustachian tube dysfunction. The average post-operative ETDQ-7 score is less than 2.1 or decrease > 0.5 (minimal clinically important difference=0.5), it is considered that the eustachian tube function is improved.
Measured: Collected at 6, 12, 24 Weeks after Tympanocentesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start12 May 2024
- Primary completion12 Nov 2024 (estimated)
- Study completion12 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media EffusionStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- 234 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Xiong, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523933
- Sponsor's protocol ID
- SYSKY-2023-448-01
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution of Bacteria in Otitis Media With Effusion After Radiotherapy For Nasopharyngeal Carcinoma.
- ClinicalTrials.gov ID
- NCT06523933
- Acronym / sponsor ID
- SYSKY-2023-448-01
- Conditions
- Otitis Media Effusion, Nasopharyngeal Carcinoma
- Keywords
- Otitis Media Effusion, Nasopharyngeal Carcinoma, Bacteria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 12 May 2024 (actual)
- Primary completion
- 12 Nov 2024 (estimated)
- Study completion
- 12 May 2025 (estimated)
- First posted
- 26 Jul 2024 (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.
To observe the prognostic difference of tympanocentesis in different kinds of otitis media effusion.
Detailed description
This study is a prospective, observational clinical study to observe the difference in prognosis of tympanocentesis in different kinds of otitis media effusion (OME), especially OME after radiotherapy for nasopharyngeal carcinoma (NPC). A total of 234 patients diagnosed with OME who are given the treatment of tympanocentesis only, including outpatient and inpatient patients, were included in the study. The middle ear effusion collected during the tympanocentesis is sent for bacterial culture. The positive rate of the effusion and the recurrence rate within 24 weeks will be compared in order to figure out whether bacterial infection is an important influencing factor for some kinds of OME in addition to eustachian tube dysfunction, which is acknowledged.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ON+ | – | –Patients with OME after NPC with a Positive Result of Bacteria Culture of Middle Ear Effusion. |
| ON- | – | –Patients with OME after NPC with a Negative Result of Bacteria Culture of Middle Ear Effusion. |
| O+ | – | –Patients with OME with a Positive Result of Bacteria Culture of Middle Ear Effusion. |
| O- | – | –Patients with OME with a Negative Result of Bacteria Culture of Middle Ear Effusion. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with OME and OME after radiotherapy for NPC, who are given the treatment of tympanostomy only, including outpatient and inpatient patients, were included in the study.
Key inclusion criteria (2 listed)
- patients clinical diagnosis of OME or OME after radiotherapy for NPC (Diagnostic criteria: fluid visible in the middle ear and a type B tympanogram).
- patients volunteered to participate in the study and signed the informed consent
Key exclusion criteria (8 listed)
- NPC recurrence or other malignant tumor after radiotherapy.
- clear diagnosis of Eustachian ostium atresia or nasal obstruction diseases, such as severe deviated nasal septum, choanal atresia, osteoradionecrosis of skull base after radiotherapy, etc.
- pregnant and lactating women.
- patients with severe underlying diseases or with severe liver and kidney dysfunction.
- patients who could not cooperate (including poor hearing and radiation encephalopathy)
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
Positive Bacterial Culture Rate in Middle Ear Effusion
Time frame: Up to 24 weeks
2 secondary outcomes
Changes in Air Pressure (Tympanogram)
Time frame: Collected at 6, 12, 24 Weeks after Tympanocentesis
Eustachian Tube Dysfunction Questionnaire (ETDQ-7)
Time frame: Collected at 6, 12, 24 Weeks after Tympanocentesis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
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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.
Hao Xiong principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 Effusion and Nasopharyngeal Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 2 inclusion and 8 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 Jul 2024. 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 China. 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?
Results are not available in the source record.
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?
Positive Bacterial Culture Rate in Middle Ear Effusion (time frame: Up to 24 weeks). 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 Jul 2024.