RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-04
Study Completion:2028-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06258837

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Child has a diagnosis of moderate to severe OSA diagnosed by PSG (oAHI ≥ 5).
  2. * Child age is 2.00 to 17.99 years of age.
  3. * Child has small tonsils (Brodsky 1+ or 2+) noted during routine physical exam.
  4. * Caregiver can provide signed and dated consent and is 18 years of age or older at the time of consent.
  5. * Caregiver can speak, read, and write in English or Spanish.
  6. * Caregiver is primary caretaker of the child.
  7. * Child is not pregnant.
  8. * Child is eligible for surgical treatment
  1. * Child has history of previous tonsillectomy, tonsillotomy, or partial tonsillectomy.
  2. * Child has any contraindication to surgery (e.g. bleeding disorders).
  3. * Child has significant cardiopulmonary comorbidity besides OSA requiring supplemental oxygen, subglottic or tracheal stenosis, tracheostomy dependence.
  4. * Child has a genetic abnormality, Down syndrome, neuromuscular disorder, craniofacial anomaly.
  5. * Caregiver is unwilling or unable to comply with study procedures.
  6. * Child is or plans to become pregnant.

Contacts and Locations

Study Contact

Eleni O'Neill
CONTACT
503-494-3569
oneilele@ohsu.edu
Derek Lam, MD
CONTACT
503-494-9419
lamde@ohsu.edu

Principal Investigator

Derek Lam, MD
PRINCIPAL_INVESTIGATOR
Oregon Health and Science University

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

  • Derek Lam, MD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-04
Study Completion Date2028-09-30

Study Record Updates

Study Start Date2024-10-04
Study Completion Date2028-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Otolaryngological Disease
  • Obstructive Sleep Apnea