RecruitingObstructive Apnea
Comparison of a Demand Oxygen Delivery
Eligible age
5–17 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this 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.
Sponsor: Children's Hospital Medical Center, Cincinnati
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Ohio
Cincinnati
Source: ClinicalTrials.gov · NCT06609694 · last updated 2026-01-07