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

RecruitingNAAges 2 Years - 17 YearsAllOregon Health and Science University
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In plain words

What the trial is, and whether it could suit you

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 pres

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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.
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What it tests

  • DISE-Directed Surgery
  • Adenotonsillectomy
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Where

7 sites
Colorado Children's Hospital
Aurora, United States
University of Michigan
Ann Arbor, United States
Cincinnati Children's Hospital
Cincinnati, United States
Oregon Health and Science University
Portland, United States
UT Southwestern Medical Center
Dallas, United States
Texas Children's Hospital
Houston, United States
EVMS Medical School
Norfolk, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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