Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609694
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-01-06
Brief Title:
Comparison of a Demand Oxygen Delivery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of a Demand Oxygen Delivery to Continuous Flow for Administration of Oxygen During Sleep
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOSA
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 methods of oxygen delivery during sleep in 15 children from Cincinnati Childrens Hospital and Childrens Hospital of Los Angeles 2 polysomnographies will be performed one with continuous flow and the second with pulse flow
The aim of the study is to conduct a comparison between the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Childrens Hospital and Childrens Hospital of Los Angeles 2 polysomnographies will be performed one with continuous flow and the second with pulse flow
Detailed Description:
Cincinnati Childrens 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 delivered through continuous flow for the duration of the respiratory cycle or pulse flow during inspiration only Pulse flow oxygen concentrators have been used clinically in adults However there is limited experience with this technology in children The advantages of pulse flow oxygen concentrator are its portability and its ability in providing compliance data
This is a pilot research study to compare the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Childrens Hospital and Childrens Hospital of Los Angeles 2 polysomnographies will be performed one with continuous flow and the second with pulse flow The pilot study is conducted in preparation for a larger project which will include 7 sites aiming at determining the effect of oxygen treatment on the frequency of obstructive apnea neurocognitive and cardiac outcomes A separate Institutional Review Board IRB protocol of the larger study will be submitted later once approved by the NIH Data and Safety Monitoring Board
This is a pilot research study to compare the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Childrens Hospital and Childrens Hospital of Los Angeles 2 polysomnographies will be performed one with continuous flow and the second with pulse flow The pilot study is conducted in preparation for a larger project which will include 7 sites aiming at determining the effect of oxygen treatment on the frequency of obstructive apnea neurocognitive and cardiac outcomes A separate Institutional Review Board IRB protocol of the larger study will be submitted later once approved by the NIH Data and Safety Monitoring Board
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None