Condition: Otolaryngological Disease · Obstructive Sleep Apnea · Sponsor: Oregon Health and Science University
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.
This description comes directly from the study's public registry record.
Eleni O'Neill · 503-494-3569 · topsst@ohsu.edu
Derek Lam, MD · 503-494-9419 · lamde@ohsu.edu
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| University of Michigan | Ann Arbor, Michigan, United States | Recruiting |
| Oregon Health and Science University | Portland, Oregon, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06258837