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Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils

RecruitingNAAges 2 Years - 17 YearsAllOregon Health and Science University
NCT06258837 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 wi

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📋 Eligibility rules (as published)
To be in the study: * 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. * Caregiver can speak, read, and write in English or Spanish. * Caregiver is primary caretaker of the child. * Child is not expecting their own child. * Child is eligible for surgical treatment Cannot be in the study if: * Child has history of previous tonsillectomy, tonsillotomy, or partial tonsillectomy. * Child has any contraindication to surgery (e.g. bleeding disorders). * Child has significant cardiopulmonary comorbidity besides OSA requiring supplemental oxygen, subglottic or tracheal stenosis, tracheostomy dependence. * Child has a genetic abnormality, Down syndrome, neuromuscular disorder, craniofacial anomaly. * Caregiver is unwilling or unable to comply with study procedures. * Child is or plans to become a parent themselves.
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What it tests

  • DISE-Directed Surgery
  • Adenotonsillectomy
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Where

2 sites
University of Michigan
Ann Arbor, United States
Oregon Health and Science University
Portland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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