Low-flow nighttime oxygen for children and teens 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-11193933 · Data updated 2026-11-12
This project tests whether nightly low-flow oxygen helps children and adolescents with Down syndrome who have moderate to severe obstructive sleep apnea.
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 | 2025 |
| Award (this year) | $4,125,108 |
| NIH project number | 5R33HL165366-04 |
| Project ID | NIH-11193933 on NIH RePORTER |
Who could benefit from this research
✓Could help
Children and adolescents aged 5 to 17 with Down syndrome and moderate to severe obstructive sleep apnea that persists after adenotonsillectomy are the ideal candidates.
✕Less likely to help
Infants, adults, people without Down syndrome, or those with mild or well-controlled OSA are unlikely to benefit from this specific trial.
What this research studies
Researchers will screen about 328 children and adolescents with Down syndrome (ages 5–17) who still have moderate to severe obstructive sleep apnea after adenotonsillectomy. In the initial R61 phase families will help refine the protocol and recruitment methods and pilot the intervention. Those who show an initial response to oxygen will be included in the R33 phase, where about 230 participants will be randomized to receive nightly low-flow oxygen or usual care. The team will measure sleep breathing events, cognition, heart function, and quality of life to see if oxygen reduces nightly low oxygen and related problems.
Why it matters
Potential benefit: If successful, nightly low-flow oxygen could reduce low-oxygen episodes during sleep and improve thinking, heart function, sleep quality, and daily life for children with Down syndrome and OSA.
How similar studies have gone: Oxygen has been used in some individual cases when other OSA treatments fail, but it has not been systematically studied in children with Down syndrome, so evidence is limited.
Where this research is happening
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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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Oxygen therapy for kids with Down syndrome and sleep apnea
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.
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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.
-
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.