Obstructive Sleep Apnea study: DISE-Directed Surgery vs Adenotonsillectomy
Official title Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)
ClinicalTrials.gov ID: NCT05508971
What this study is testing
- What it's testing
- The study aims to find out whether surgery planned using drug‑induced sleep endoscopy works better than the usual adenotonsillectomy for treating sleep apnea in these children.
- Who it's for
- Children with Down syndrome who have been diagnosed with obstructive sleep apnea.
- What's involved
- Participants are randomly assigned to either a personalized surgery plan based on a sleep endoscopy exam or the standard adenotonsillectomy; they will undergo the procedures, sleep tests, and follow‑up visits.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Child has a diagnosis of Down syndrome (Trisomy 21). Child has a diagnosis of moderate to severe OSA diagnosed by PSG (oAHI ≥ 5).
- 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 has history of previous tonsillectomy, tonsillotomy, or partial tonsillectomy.
- Child has any contraindication to surgery (e.g. bleeding disorders).
- Caregiver is unwilling or unable to comply with study procedures. Child is or plans to have their own child.
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
- Ann Arbor, Michigan, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Norfolk, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States; Ann Arbor, Michigan, United States; Portland, Oregon, United States; Dallas, Texas, United States; Houston, Texas, United States; Norfolk, Virginia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.