Personalized surgery for obstructive sleep apnea in children with Down syndrome

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Colorado Children's Hospital
  Aurora, Colorado, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States 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 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
• Email: topsds@ohsu.edu
• Phone: 503-875-9895

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Oxygen therapy for children with Down Syndrome and sleep apnea

  This study is testing whether giving extra oxygen during sleep can help improve thinking skills and overall health in children with Down Syndrome who have sleep apnea.

  Recruiting at 7 sites Phase 2 Brigham and Women's Hospital · Los Angeles, California and 6 other locations · NCT06043440

• Evaluating non-invasive ventilation for sleep apnea in children with Down syndrome

  This study is trying to see if using a non-invasive breathing machine can help children with Down syndrome who have sleep apnea sleep better and improve their quality of life.

  Recruiting at 2 sites Children's Health Ireland · Dublin and 5 other locations · NCT06030349

• Using a special airway device to treat sleep apnea in children with weak muscles

  This study is testing a special airway device to see if it can help children with weak muscles who have sleep apnea breathe better at night without needing surgery.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT05527652

• Multimodal Deep Learning to Predict Sleep Apnea Severity from SpO2 and Ballistocardiography

  Researchers are testing a smart-mattress-based method that uses SpO2 and ballistocardiography data to predict sleep apnea severity in adults undergoing overnight sleep study.

  Recruiting Fu Jen Catholic University · New Taipei City, New Taipei City · NCT07923825

• Nightly wearable monitoring with at-home submental electrical stimulation for sleep apnea

  This pilot test checks whether wearing a ring sensor at night and doing a 4-week at-home submental electrical stimulation is feasible for adults with obstructive sleep apnea and looks at changes in sleep metrics.

  Recruiting E-DA Hospital · Kaohsiung City · NCT07921329

• Functional capacity and muscle function in adults with obstructive sleep apnea

  This study tests how obstructive sleep apnea affects respiratory and peripheral muscle strength, endurance, and upper‑extremity function compared with healthy adults.

  Recruiting Karabuk University · Karabük · NCT07913139

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.