Comparing Oxygen Delivery Methods for Obstructive Sleep Apnea in Children
This research study is comparing two ways to deliver oxygen during sleep for children aged 5 to 17 who have obstructive sleep apnea (OSA). OSA is when breathing repeatedly stops and starts during sleep. The study is testing a portable oxygen concentrator called the Inogen G5 model, which delivers oxygen in pulses during breathing, against continuous oxygen flow. We want to see if the Inogen G5 can reduce the Apnea Hypopnea Index (AHI), which measures how often breathing stops or becomes very shallow during sleep, by at least 50% or to less than 5 events per hour. This study is for children with moderate to severe OSA, including those with Down Syndrome. The study aims to enroll 10 participants.
- Study design
- This is an interventional pilot study comparing two methods of oxygen delivery. It plans to enroll 10 participants.
- What's involved
- Participants will undergo two sleep studies (polysomnographies), one with continuous oxygen flow and one with pulse flow oxygen.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, a drop in the Apnea Hypopnea Index, will be measured at 6 months.
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Comparison of a Demand Oxygen Delivery
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Raouf Amin, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati
Who to contact
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What this trial measures
- Drop in Apnea Hypopnea Index (0-4 /night) by 50 % or < 5 /hour6 months
Percent of children with a drop in Apnea Hypopnea Index (AHI) by 50% or \< 5 /hour