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Comparison of a Demand Oxygen Delivery
Comparison of a Demand Oxygen Delivery to Continuous Flow for Administration of Oxygen During Sleep
Who can join
Ages 5 to 17 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: 1. Age 5-17 years with or without Down Syndrome (DS). 2. 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). 3. 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 Criteria: 1. Current CPAP use with documented compliance (\> 4 hrs/ night; \> 70% of nights). 2. Oxygen saturation \< 90% at rest during wakefulness 3. Chronic daytime or nighttime use of supplemental oxygen. 4. Unable to participate in a Polysomnogram (PSG). 5. Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.
About the study
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.
What is being tested
- Portable oxygen concentrator Inogen G5 model (device)
Sponsor: Children's Hospital Medical Center, Cincinnati · Participants: 10 · Started: Jan 9, 2023
Contact the study team
- Suzie Hicks, BS · Phone: 513-636-4944
Official record on ClinicalTrials.gov — NCT06609694
Locations in the U.S.
| Ohio | Cincinnati Children's Hospital Medical Center, Cincinnati |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.