New study tests lighter oxygen device for kids with sleep apnea
NCT ID NCT06609694
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two methods of delivering oxygen during sleep in children aged 5-17 with Down syndrome and moderate to severe obstructive sleep apnea. Ten participants will have two sleep studies—one with continuous oxygen flow and one with pulse flow from a portable concentrator. The goal is to see if pulse flow can reduce breathing pauses and maintain healthy oxygen levels as well as continuous flow.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- portable oxygen concentrator (Inogen G5)
- What this could lead to
- If successful, this could show that pulse-flow oxygen works as well as continuous-flow for treating sleep apnea in children with Down syndrome, offering a lighter, more convenient option.
- What could go wrong
- This is a very small early study with only 10 children, so results may not apply to everyone. The oxygen settings are adjusted manually, which could affect consistency.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cincinnati Children's Hospital Medical Center
RECRUITINGCincinnati, Ohio, 45229, United States
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