Personalized surgery for children with small tonsils and obstructive sleep apnea
Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils
This study is testing whether a personalized surgery using a special sleep test can help children with small tonsils and sleep apnea feel better compared to the standard tonsil removal surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Trial ID | NCT06258837 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 17 years with a diagnosis of moderate to severe OSA and small tonsils.
Not a fit: Patients who have had previous tonsil surgeries or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for children with obstructive sleep apnea and reduce unnecessary surgeries.
How similar studies have performed: While personalized surgical approaches have shown promise in adults, this specific application in children with small tonsils is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ann Arbor, Michigan and 1 other locations
- 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: oneilele@ohsu.edu
- Phone: 503-494-3569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.