Oxygen therapy for kids with Down syndrome and sleep apnea
Official title: Randomized Control Trial of oxygen therapy in Children and Adolescents with Down Syndrome and Obstructive Sleep Apnea
Funded at Cincinnati Childrens Hosp Med Ctr · NIH-11411366 · Data updated 2026-11-12
A study tests whether low-flow oxygen helps children with Down syndrome and moderate to severe obstructive sleep apnea who have not benefited from first-line surgery.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Cincinnati Childrens Hosp Med Ctr NIH-funded |
| Lab location | 1 site (Cincinnati, United States) |
| Project start | September 1, 2022 |
| Project end | August 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $3,919,962 |
| NIH project number | 5R33HL165366-05 |
| Project ID | NIH-11411366 on NIH RePORTER |
Who could benefit from this research
✓Could help
Children aged 5-17 with Down syndrome and moderate to severe obstructive sleep apnea who failed adenotonsillectomy.
✕Less likely to help
Children without Down syndrome, without sleep apnea, or whose OSA is already well-controlled by other therapies may not benefit.
What this research studies
This trial will enroll hundreds of children aged 5 to 17 with Down syndrome and moderate to severe sleep apnea who did not improve after adenotonsillectomy. In two phases, researchers will first refine the study protocol with families and then randomize about 230 children to receive oxygen plus standard care versus standard care alone to see if oxygen reduces nighttime breathing problems and improves sleep. The team will monitor safety, cognitive function, heart health, sleep quality, and quality of life over time. The goal is to determine if oxygen can be a safe, effective option for managing OSA in this specific population.
Why it matters
Potential benefit: If successful, children with Down syndrome and OSA may experience better sleep, improved thinking and learning, and overall better health.
How similar studies have gone: Previous small studies suggest potential benefits of oxygen in specific OSA cases, but large randomized data in this population are needed.
Where this research is happening
-
Cincinnati Childrens Hosp Med Ctr
Cincinnati, United States Active
Researchers
- Principal investigator: Amin, Raouf S. — Cincinnati Childrens Hosp Med Ctr
- Study coordinator: Amin, Raouf S.
Related research
Other NIH-funded projects on the same topics.
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Personalized DISE-guided surgery for sleep apnea in children with Down syndrome
A personalized surgical approach guided by DISE sleep-endoscopy is being tested to better treat sleep apnea in children with Down syndrome who don’t always improve after standard surgery.
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Low-flow nighttime oxygen for children and teens with Down syndrome and sleep apnea
This project tests whether nightly low-flow oxygen helps children and adolescents with Down syndrome who have moderate to severe obstructive sleep apnea.
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Medications to treat sleep apnea and boost thinking in children with Down syndrome
This project gives a combination of two commonly used medicines, atomoxetine and oxybutynin, to children with Down syndrome who have obstructive sleep apnea to see if it helps them sleep better and think more clearly.
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Testing oxygen therapy for children with Down Syndrome and sleep apnea
This study is looking at whether low-flow oxygen therapy can help kids and teens with Down Syndrome who have trouble breathing while sleeping, aiming to see if it can make them feel better and improve their daily lives, especially for those who haven't found relief with other treatments.
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Personalized surgery for sleep apnea in children with Down syndrome
This trial will see if using sleep endoscopy to guide personalized airway surgery helps children with Down syndrome who have obstructive sleep apnea.
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Using positive airway pressure to treat sleep apnea in children with Down syndrome
This study is looking at how well a special breathing machine called PAP therapy helps kids with Down syndrome and sleep apnea, by comparing a six-month hands-on support program to regular care, to see which helps them stick with the treatment better and feel better overall.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.