RecruitingNot ApplicableNCT06258837

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


Sponsor

Oregon Health and Science University

Enrollment

240 participants

Start Date

Oct 4, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Adenotonsillectomy and a procedure called DISE-Directed Surgery for people with obstructive sleep apnea and otolaryngological disease. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 2 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREDISE-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.

PROCEDUREAdenotonsillectomy

Tonsil and/or adenoid removal


Locations(2)

University of Michigan

Ann Arbor, Michigan, United States

Oregon Health and Science University

Portland, Oregon, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06258837


Related Trials