Actively Recruiting
Comparison of a Demand Oxygen Delivery
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-01-07
10
Participants Needed
1
Research Sites
307 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of a Demand Oxygen Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 5-17 years with or without Down Syndrome
- Diagnosis of obstructive sleep apnea with an obstructive apnea hypopnea index between 5 and 40 per hour
- No clinically significant hypoxia defined as oxygen saturation below 88% for 5 minutes or episodic desaturation to 60%
You will not qualify if you...
- Current use of CPAP with documented compliance of more than 4 hours per night on over 70% of nights
- Oxygen saturation below 90% at rest during wakefulness
- Chronic use of supplemental oxygen during day or night
- Inability to participate in a polysomnogram
- Enrollment in another study that may conflict with this trial or affect results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
S
Suzie Hicks, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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