Comparison of a Demand Oxygen Delivery to Continuous Flow for Administration of Oxygen During Sleep

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: t
View:

• 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.

Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Suzie Hicks, BS
suzie.hicks@cchmc.org
513-636-4944
Time Frame
Start Date: 2023-01-09
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 10
Treatments
Experimental: Inogen portable oxygen concentrator unit versus continuous flow (Pilot Study)
The aim of this pilot study is to examine whether clinically important indices during sleep are comparable between oxygen delivery by portable and by continuous flow.
Experimental: Reducing the frequency of obstructive apnea (Main study)
The arm of the main study is still under development
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov