Otitis Media With Effusion and Type 2 Inflammation Diseases

NCT06403319 | Completed

• 1 other identifier: OME-S-24-00723
• Study Type: observational
• Target: 100,622
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Otitis Media With Effusion

Outcome Measures

Primary Outcomes (1)

• The number of participants with OME who requiring surgical intervention

  surgical intervention including procedures such as myringotomy and adenoidectomy

  10 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Otitis Media with Effusion

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 7, 2024
• Study Start: January 1, 2009
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 7, 2024

Record last verified: 2024-05