Personalized Surgery for Obstructive Sleep Apnea in Children with Down Syndrome
This study, called TOPS-DS, is looking at better ways to treat obstructive sleep apnea (OSA) in children with Down syndrome. OSA is when breathing stops and starts during sleep, which is very common in children with Down syndrome. The study will compare two surgical approaches: Adenotonsillectomy (removing tonsils and adenoids) and DISE-Directed Surgery, which is a personalized surgery based on a detailed examination of the child's airway. Researchers want to see if these surgeries improve breathing during sleep. To join, your child must be between 2 and 17 years old, have Down syndrome, and have moderate to severe OSA. The study aims to enroll 304 children, but its current status is unclear.
- Study design
- This is an interventional study comparing two surgical procedures in 304 participants. It is a randomized clinical trial, meaning participants are assigned to one of the two treatment groups by chance.
- What's involved
- Participants will undergo a sleep study before surgery and again 6 months after surgery. They will receive either Adenotonsillectomy or DISE-Directed Surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 6 months after surgery to assess changes in their sleep study results.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)
At a glance
Conditions
Where it's being run
7 sites across 6 statesStudy leadership
- Derek Lam, MD, MPH · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University
Who to contact
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What this trial measures
- Change from Baseline Polysomnography Measures: oAHI at 6 months6 month follow up sleep study (after surgery)
Objective results from sleep studies (polysomnography): Obstructive Apnea-Hypopnea Index (oAHI): 6 months follow up sleep study difference from baseline sleep study
- Change from Baseline Polysomnography Measures: AHI at 6 months6 month follow up sleep study (after surgery)
Objective results from sleep studies (polysomnography): Total Apnea-Hypopnea Index: 6 months follow up sleep study difference from baseline sleep study
- Change from Baseline Polysomnography Measures: REM AHI at 6 months6 month follow up sleep study (after surgery)
Objective results from sleep studies (polysomnography): REM Apnea-Hypopnea Index REM AHI: 6 months follow up sleep study difference from baseline sleep study
- Change from Baseline Polysomnography Measures: min SpO2 at 6 months6 month follow up sleep study (after surgery)
Objective results from sleep studies (polysomnography): Minimum Oxygen Saturation (Min SpO2): 6 months follow up sleep study difference from baseline sleep study
- Change from Baseline Polysomnography Measures: desat index at 6 months6 month follow up sleep study (after surgery)
Oxyhemoglobin desaturation ≥ 3% Index: 6 months follow up sleep study difference from baseline sleep study
- Change from Baseline Polysomnography Measures: % Total Sleep Time with ETCO2 > 50 mmHg at 6 months6 month follow up sleep study (after surgery)
% Total Sleep Time with ETCO2 \> 50 mmHg: 6 months follow up sleep study difference from baseline sleep study
- Change from Baseline Polysomnography Measures: Max End Tidal CO2 (ETCO2) at 6 months6 month follow up sleep study (after surgery)
Max End Tidal CO2 (ETCO2): 6 months follow up sleep study difference from baseline sleep study