Comparison of a Demand Oxygen Delivery
Key facts
- Where
- Cincinnati, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 17 years old?
Source: NCT06609694, who can take part
Where in United States
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesContact: Suzie Hicks, BSTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Children's Hospital Medical Center, Cincinnati
- Trial code
- NCT06609694
- Record updated
- 7 January 2026
- Original description
Conducting a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea.Read full original descriptionShow less
Comparison of a Demand Oxygen Delivery to Continuous Flow for Administration of Oxygen During Sleep
Conducting a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea.
The aim of the study is to conduct a comparison between the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los Angeles. 2 polysomnographies will be performed, one with continuous flow and the second with pulse flow.
Inclusion: Age 5-17 years with or without Down Syndrome (DS); Children with obstructive sleep apnea (OSA) and obstructive apnea hypopnea index (OAHI) 5-40 / hour: The rationale for selecting this range of OAHI is that a large number of children with DS with this range of OSA severity are untreated for months to years. It is important to understand the response to oxygen across the spectrum of disease severity. Notably, children with severe disease are left with few options (e.g., tracheostomy); Absence of clinically significant hypoxia defined as oxygen saturation < 88% for 5 minutes or episodic desaturation to 60% as these levels would otherwise identify children eligible to routinely receive oxygen.
Exclusion: Current CPAP use with documented compliance (> 4 hrs/ night; > 70% of nights); Oxygen saturation < 90% at rest during wakefulness; Chronic daytime or nighttime use of supplemental oxygen; Unable to participate in a Polysomnogram (PSG); Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.