Personalized surgery for obstructive sleep apnea in children with Down syndrome

Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)

This study is testing a personalized surgery approach to treat obstructive sleep apnea in children with Down syndrome to see if it works better than standard surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 303 (estimated)
• Ages: 2 Years to 17 Years
• Sex: All
• Sponsor: Oregon Health and Science University (Academic / other)
• Locations: 7 sites (Aurora, Colorado and 6 other locations)
• Trial ID: NCT05508971 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a personalized surgical approach for treating obstructive sleep apnea (OSA) in children with Down syndrome. Given the high prevalence of OSA in this population, the study will utilize drug-induced sleep endoscopy (DISE) to identify specific anatomical issues contributing to OSA, followed by tailored surgical interventions. The trial will include children aged 2 to 17 years who have been diagnosed with moderate to severe OSA. The goal is to improve surgical outcomes compared to traditional adenotonsillectomy, which has shown limited effectiveness in this group.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 to 17 years with Down syndrome and moderate to severe obstructive sleep apnea.

Not a fit: Patients with a history of previous tonsillectomy or significant cardiopulmonary comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life and health outcomes for children with Down syndrome suffering from obstructive sleep apnea.

How similar studies have performed: While there have been studies on adenotonsillectomy in children, this personalized surgical approach using DISE is novel and has not been extensively tested in this specific population.

Eligibility criteria

Requirements to participate in study:

Child has a diagnosis of Down syndrome (Trisomy 21). 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. 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 participate in 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.

Caregiver is unwilling or unable to comply with study procedures. Child is or plans to have their own child.

Where this trial is running

Aurora, Colorado and 6 other locations

• Colorado Children's Hospital — Aurora, Colorado, United States (Not_yet_recruiting)
• University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States (Active_not_recruiting)
• Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
• UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
• Texas Children's Hospital — Houston, Texas, United States (Not_yet_recruiting)
• EVMS Medical School — Norfolk, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Derek Lam, MD, MPH — Oregon Health and Science University
• Study coordinator: Eleni O'Neill

Conditions Obstructive Sleep Apnea; Down Syndrome