Comparison of a Demand Oxygen Delivery

Children's Hospital Medical Center, Cincinnati10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Obstructive Apnea

Interventions

Portable oxygen concentrator Inogen G5 modelDEVICE

The concentrator weighs 4.7 lbs. and has a battery life of 13 hours. It has 6 settings with 1 providing the lowest pulse flow and 6 provides the highest flow. The setting will be increased every 30 minutes by 1 when oxygen nadir is lower than 94% and or obstructive index is ≥ 5 /hour.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

Drop in Apnea Hypopnea Index (0-4 /night) by 50 % or < 5 /hour

Percent of children with a drop in Apnea Hypopnea Index (AHI) by 50% or \< 5 /hour

Time frame: 6 months

Secondary Outcomes

Value of Oxygen Saturation (SpO2)

The total value of how much oxygen saturation happens while sleeping will be measured at baseline and 6 month visit.

Time frame: 6 months

Percentage of Oxygen Saturation (SpO2) and number of times it goes below 90%

At the baseline and 6 month visit will measure the number of times that SpO2 falls below 90% will sleeping.

Time frame: 6 months

Pulse Rate during sleep

Mean pulse rate during the total sleep time (beats per min) as well as the maximum pulse rate will be captured during sleep.

Time frame: 6 months

Frequency of apnea happening during sleep

The total number of apnea events occurring per hour will be measured during sleep

Time frame: 6 months

Total hours of Sleep Time

Total sleep time will be confirmed by an electroencephalogram (h)

Time frame: 6 months

Central Contacts

Suzie Hicks, BS

CONTACT

513-636-4944 suzie.hicks@cchmc.org

Data from ClinicalTrials.gov

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