Testing oxygen therapy for children 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-10972922 · Data updated 2026-11-12
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.
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 | 2024 |
| Award (this year) | $4,300,526 |
| NIH project number | 4R33HL165366-03 |
| Project ID | NIH-10972922 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are children aged 5 to 17 years with Down Syndrome and moderate to severe obstructive sleep apnea who have not benefited from previous surgical interventions.
✕Less likely to help
Patients who do not have Down Syndrome or those with mild obstructive sleep apnea may not receive any benefit from this research.
What this research studies
This research investigates the effects of low-flow oxygen therapy on children and adolescents with Down Syndrome who suffer from obstructive sleep apnea (OSA). The study aims to determine if oxygen can improve symptoms related to OSA, such as cognitive impairment and reduced quality of life, especially in those who have not responded well to other treatments. Families of participants will be actively engaged in the research process to ensure that the study meets their needs and expectations. Approximately 328 children will be screened, and 230 will be randomized to receive either oxygen therapy or standard care.
Why it matters
Potential benefit: If successful, this research could provide a new treatment option that significantly improves cognitive function and quality of life for children with Down Syndrome and obstructive sleep apnea.
How similar studies have gone: While oxygen therapy has been used in some cases, this specific approach has not been systematically studied in this population, making it a novel investigation.
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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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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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.