NIH-funded research NIH-funded research

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.

More Down Syndrome research and trials

Quick facts

Grant typeNIH-funded research
Study typeNIH-funded research
Funding institutionCincinnati Childrens Hosp Med Ctr
NIH-funded
Lab location1 site (Cincinnati, United States)
Project startSeptember 1, 2022
Project endAugust 31, 2027
Funding year2026
Award (this year)$3,919,962
NIH project number5R33HL165366-05
Project IDNIH-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.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.