Comparison of a Demand Oxygen Delivery (DOSA)

Cincinnati Children's Hospital Medical Center

Status: Enrolling

Conditions: Obstructive Apnea

Treatments: Device: Portable oxygen concentrator Inogen G5 model

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06609694

R61HL165366 (U.S. NIH Grant/Contract)

2022-0821

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Inogen portable oxygen concentrator unit versus continuous flow (Pilot Study)

Experimental group

Description:

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.

Treatment:

Device: Portable oxygen concentrator Inogen G5 model

Reducing the frequency of obstructive apnea (Main study)

Experimental group

Description:

The arm of the main study is still under development

Treatment:

Device: Portable oxygen concentrator Inogen G5 model