NCT06258837 Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils
| NCT ID | NCT06258837 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oregon Health and Science University |
| Condition | Otolaryngological Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 175 participants |
| Start Date | 2024-10-04 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 175 participants in total. It began in 2024-10-04 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Derek Lam, MD
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT06258837 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Otolaryngological Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06258837 currently recruiting?
Yes, NCT06258837 is actively recruiting participants. Contact the research team at topsst@ohsu.edu for enrollment information.
Where is the NCT06258837 trial being conducted?
This trial is being conducted at Ann Arbor, United States, Portland, United States.
Who is sponsoring the NCT06258837 clinical trial?
NCT06258837 is sponsored by Oregon Health and Science University. The principal investigator is Derek Lam, MD at Oregon Health and Science University. The trial plans to enroll 175 participants.