Condition: Obstructive Sleep Apnea · Down Syndrome · Sponsor: Oregon Health and Science University
The overall objective of this randomized clinical trial is to test the effectiveness of a personalized approach to the surgical treatment of OSA in children with Down syndrome (DS).The estimated prevalence of obstructive sleep apnea (OSA) in children with DS ranges from 45-83%, compared to 1-6% in the general pediatric population. Untreated OSA in children has been associated with daytime sleepiness, cognitive or behavioral problems, and cardiovascular complications, all which are common in children with DS. Adenotonsillectomy (AT) is the first line treatment for OSA in children, however, most large studies of AT outcomes have excluded children with DS. Available evidence demonstrates that AT is far less effective in children with DS than in the general pediatric population, with 48 to 95% of children with DS having persistent OSA after AT. Medical treatments such as positive airway pressure (PAP) therapy are frequently inadequate or poorly tolerated in this population, so many children with DS and OSA remain untreated. Drug-induced sleep endoscopy (DISE) enables direct observation of the sites and patterns of obstruction during sedated sleep using a flexible endoscope passed through the nose into the pharynx. DISE was developed to guide surgical decisions in adult OSA, and in recent years has also been used to design personalized surgical interventions in children. Using this DISE Rating Scale, the investigators have demonstrated that children with DS are more prone to tongu…
This description comes directly from the study's public registry record.
Eleni O'Neill · 503-875-9895 · topsds@ohsu.edu
Derek Lam, MD · 503-494-9419 · lamde@ohsu.edu
Always discuss trial participation with your own doctor first.
| Colorado Children's Hospital | Aurora, Colorado, United States | Recruiting |
| University of Michigan | Ann Arbor, Michigan, United States | Recruiting |
| Cincinnati Children's Hospital | Cincinnati, Ohio, United States | Terminated |
| 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 |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT05508971