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Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils
Sponsor: Oregon Health and Science University
Summary
The purpose of this study is to compare the effectiveness of a novel personalized surgical approach to the standard AT in children with small tonsils (ST). This will be accomplished by randomizing children with ST and OSA to one of these two treatments and comparing outcomes after 6 months. It is the investigators' central hypothesis that a personalized drug-induced sleep endoscopy (DISE)-directed surgical approach that uses existing procedures to address the specific fixed and dynamic anatomic features causing obstruction (ie, anatomic endotypes) in each child with ST will perform better than the currently recommended standard first line approach of AT. This novel approach may improve OSA outcomes and reduce the burden of unnecessary AT or secondary surgery for persistent OSA after an ineffective AT. To test this hypothesis, the investigators propose to study children aged 2-17 years with small tonsils and OSA.
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2024-10-04
Completion Date
2028-09-30
Last Updated
2025-09-24
Healthy Volunteers
No
Interventions
DISE-Directed Surgery
Participants randomized to DISE-directed surgery will undergo one or more potential procedures in a single surgery (i.e. DISE and subsequent sleep surgery performed) concurrently under the same general anesthetic), depending on anatomic assessment.
Adenotonsillectomy
Tonsil and/or adenoid removal
Locations (2)
University of Michigan
Ann Arbor, Michigan, United States
Oregon Health and Science University
Portland, Oregon, United States