About this trial
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.
Eligibility criteria
Qualifiers
Child has a diagnosis of moderate to severe OSA diagnosed by PSG (oAHI ≥ 5).
Child age is 2.00 to 17.99 years of age.
Child has small tonsils (Brodsky 1+ or 2+) noted during routine physical exam.
Caregiver can provide signed and dated consent and is 18 years of age or older at the time of consent.
Disqualifiers
None
Trial design
Treatments tested in this trial
- DISE-Directed Surgery
- Adenotonsillectomy
Treatment groups
Sponsors and collaborators
Oregon Health and Science University
Lead sponsor
University of Michigan
Collaborator