Low-flow nighttime oxygen for children and teens with Down syndrome and sleep apnea
Randomized Control Trial of oxygen therapy in Children and Adolescents with Down Syndrome and Obstructive 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.
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 ID | NIH-11193933 on NIH RePORTER |
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.
Who could benefit from this research
Good fit: 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.
Not a fit: Infants, adults, people without Down syndrome, or those with mild or well-controlled OSA are unlikely to benefit from this specific trial.
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 performed: 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
Cincinnati, United States
- 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.
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 below.