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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-17
SponsorOregon Health and Science University

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

175 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Oregon Health and Science University

Lead sponsor

University of Michigan

Collaborator