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CompletedNCT06403319Updated May 7, 2024

Otitis Media With Effusion and Type 2 Inflammation Diseases

An observational study in Otitis Media With Effusion, sponsored by Hearing and Language Healthcare Center, China Medical University Hsinchu Hospital, Taiwan. Completed. Per ClinicalTrials.gov, last updated 2024-05-07.

Sponsored by Hearing and Language Healthcare Center, China Medical University Hsinchu Hospital, Taiwan · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100,622
Sex
All
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Study summary

Otitis media with effusion (OME) is thought to be associated with comorbidities such as allergic rhinitis, gastroesophageal reflux disease, asthma, and more. Many of these comorbidities can be caused by type 2 inflammation (T2I). This study aims to characterize the risk of undergoing OME surgery. This retrospective, matched-cohort study involved the retrospective recruitment of patients from 2009 to 2020, using the Taiwan National Health Insurance Research Database (NHIRD)

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Conditions studied

  • Otitis Media With Effusion
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In context

Otitis Media with Effusion

88 studies on the registry are indexed under Otitis Media with Effusion; 17 are open to participants now.

This study's enrollment of 100,622 is above the median of 150 across 21 observational studies indexed under Otitis Media with Effusion.

Browse Otitis Media with Effusion studies →

Lead sponsor

Hearing and Language Healthcare Center, China Medical University Hsinchu Hospital, Taiwan is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All study subjects with OME-confirmed by at least two outpatient visits or one hospitalization record within NHIRD database. We excluded cases that did not meet the following criteria: patients who had undergone OME surgery before the index date, individuals younger than 4 years old, patients with unknown demographic information, individuals in the comparison cohort with a history of T2I diseases, and patients with a history of ear surgery or congenital ear anomalies.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of OME
  • At least two outpatient visits or one hospitalization record
  • Medical records within the database

Exclusion criteria

Exclusion Criteria:

  • Participants younger than 4 years old
  • Participants with unclear demographic information
  • Participants with a history of ear surgery or congenital ear anomalies
  • Participants who had undergone OME surgery before the index date
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100,622 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. The number of participants with OME who requiring surgical intervention

    surgical intervention including procedures such as myringotomy and adenoidectomy

    Time frame: 10 years

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Study locations

No study locations are listed for this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2009 to primary completion in Dec 2020, 143 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 1, 2024
First posted
May 7, 2024
StartActual
Jan 1, 2009
Primary completionActual
Dec 31, 2020
CompletionActual
Dec 31, 2020
Last update
May 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06403319
Lead sponsor
Hearing and Language Healthcare Center, China Medical University Hsinchu Hospital, Taiwan
Responsible party
Sponsor
First posted
May 7, 2024
Start date
Jan 1, 2009
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
May 7, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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