Personalized surgery for children with small tonsils and obstructive sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of a personalized surgical approach using drug-induced sleep endoscopy (DISE) against the standard adenotonsillectomy (AT) in children aged 2-17 with small tonsils and obstructive sleep apnea (OSA). Children will be randomized to receive either DISE-directed surgery or AT, with outcomes assessed after six months. The hypothesis is that the personalized approach will yield better results by addressing specific anatomical features causing obstruction. This research seeks to fill the knowledge gap regarding the treatment of OSA in children with small tonsils, which is currently underexplored.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Oregon Health and Science University
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Derek Lam, MD — Oregon Health and Science University
• Study coordinator: Eleni O'Neill
• Email: topsst@ohsu.edu
• Phone: 503-494-3569

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.