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

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · Aug 18, 2022

Keywords

ClinConnect Summary

The TOPS-DS trial is studying a new way to treat obstructive sleep apnea (OSA) in children with Down syndrome. OSA is a condition where a child's breathing is interrupted during sleep, and it can lead to problems like sleepiness during the day, trouble with learning, and heart issues. Children with Down syndrome are at a much higher risk for OSA compared to other kids. This trial aims to see if a personalized surgical approach, guided by special observations made during sleep, can be more effective than the typical first treatment, which is called adenotonsillectomy (removing the tonsils and adenoids).

To be eligible for this trial, children must be between 2 and 17 years old, have Down syndrome, and have moderate to severe OSA. Their caregivers must be able to provide consent and speak either English or Spanish. Participants will undergo tests to determine their specific needs and then receive a tailored surgical procedure to help improve their breathing during sleep. This approach hopes to provide better outcomes and reduce unnecessary surgeries in the future.

Gender

ALL

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.