Status:
RECRUITING
Comparison of a Demand Oxygen Delivery
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obstructive Apnea
Eligibility:
All Genders
5-17 years
Phase:
NA
Brief Summary
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 metho...
Detailed Description
Cincinnati Children's Hospital received NIH funding to conduct a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea. Oxygen may be de...
Eligibility Criteria
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.
Key Trial Info
Start Date :
January 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06609694
Start Date
January 9 2023
End Date
December 1 2028
Last Update
January 7 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229