Comparison of a Demand Oxygen Delivery
ConditionObstructive Apnea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Portable oxygen concentrator Inogen G5 model
Treatment groups
10 Participants
are divided into 2 treatment groupsSponsors and collaborators
Children's Hospital Medical Center, Cincinnati
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov