Comparison of a Demand Oxygen Delivery

Not Applicable

Recruiting

• Conditions: Obstructive Apnea
• Interventions: Device: Portable oxygen concentrator Inogen G5 model

• Registration Number: NCT06609694
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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 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.

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 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 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. 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 Timeline

• Study First Submitted: 2023-01-06
• Study Start: 2023-01-09
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-19
• Last Update Submitted: 2024-09-19
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24
• Primary Completion: 2025-06-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Age 5-17 years with or without Down Syndrome (DS).
2. 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).
3. 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 Criteria

1. Current CPAP use with documented compliance (> 4 hrs/ night; > 70% of nights).
2. Oxygen saturation < 90% at rest during wakefulness
3. Chronic daytime or nighttime use of supplemental oxygen.
4. Unable to participate in a Polysomnogram (PSG).
5. Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Inogen portable oxygen concentrator unit versus continuous flow (Pilot Study)	Portable oxygen concentrator Inogen G5 model	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.
Reducing the frequency of obstructive apnea (Main study)	Portable oxygen concentrator Inogen G5 model	The arm of the main study is still under development

Primary Outcome Measures

Name	Time	Method
Drop in Apnea Hypopnea Index (0-4 /night) by 50 % or < 5 /hour	6 months	Percent of children with a drop in Apnea Hypopnea Index (AHI) by 50% or \< 5 /hour

Secondary Outcome Measures

Name	Time	Method
Value of Oxygen Saturation (SpO2)	6 months	The total value of how much oxygen saturation happens while sleeping will be measured at baseline and 6 month visit.
Percentage of Oxygen Saturation (SpO2) and number of times it goes below 90%	6 months	At the baseline and 6 month visit will measure the number of times that SpO2 falls below 90% will sleeping.
Pulse Rate during sleep	6 months	Mean pulse rate during the total sleep time (beats per min) as well as the maximum pulse rate will be captured during sleep.
Frequency of apnea happening during sleep	6 months	The total number of apnea events occurring per hour will be measured during sleep
Total hours of Sleep Time	6 months	Total sleep time will be confirmed by an electroencephalogram (h)

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States