MedTrace Logo

Surgical Treatment of Children With OSA and Small Tonsils or Down Syndrome

NCT05154214 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-09-29

No results posted yet for this study

Summary

The purpose of this study is to prospectively compare the effectiveness of a novel personalized approach to the surgical treatment of obstructive sleep apnea (OSA) in children, drug induced sleep endoscopy (DISE) directed surgery versus the standard adenotonsillectomy (AT). This will also serve to test the feasibility of recruiting families for a future randomized protocol comparing the same surgical techniques. It is the investigators' central hypothesis that a personalized 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 small tonsils or Down syndrome will be superior to 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 will study children aged 2 to 18 years with clinically small tonsils (Brodsky score 1+ or 2+ on a scale 1+ to 4+) OR Down syndrome.

Conditions

  • Obstructive Sleep Apnea of Child

Interventions

PROCEDURE

Adenotonsillectomy

Removal of tonsils and adenoids

PROCEDURE

Drug-induced sleep endoscopy directed surgery

Surgeries selected based on direct visualization of airway collapse using endoscopy during drug-induced sleep

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Derek J Lam, MD · Oregon Health and Science University

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-09
Primary Completion
2024-10-11
Completion
2024-10-11

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05154214 on ClinicalTrials.gov