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OpenTrials
Completed

NCT Number: NCT06403319

Otitis Media With Effusion and Type 2 Inflammation Diseases

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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Key information

Conditions

OTITIS MEDIA WITH EFFUSION Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Primary outcomes

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

    Time frame: 10 years

    surgical intervention including procedures such as myringotomy and adenoidectomy

Sponsors and collaborators

Lead sponsor

Hearing and Language Healthcare Center, China Medical University Hsinchu Hospital, Taiwan

Other

Registry information

Official study title

Otitis Media With Effusion Among Patients With Type 2 Inflammation Diseases

Important dates

Study start
2009
Primary completion
2020
Study completion
2020
First posted
May 7, 2024
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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