New wearable could make sleep apnea diagnosis easier for kids
NCT ID NCT05052216
First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 10 times
Summary
This study is testing a wearable sensor that measures oxygen levels in the brain and limbs of children with and without obstructive sleep apnea (OSA). The sensor, called near-infrared spectroscopy (NIRS), is compared to standard sleep study techniques. Researchers hope it could lead to a simpler, point-of-care device for diagnosing and monitoring pediatric OSA. The study involves 120 children aged 3-12, with one overnight visit for healthy kids and two for those with OSA.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- near-infrared spectroscopy (NIRS) wearable sensor
- What this could lead to
- If successful, this could lead to a simpler, more comfortable way to diagnose and monitor sleep apnea in children at home.
- What could go wrong
- This is an early-stage study with only 120 participants, so the device may not prove accurate enough to replace standard sleep studies. It also requires overnight visits, which may not reflect real-world home use.
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.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2022
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
subjects enrolled in other sleep studies, subjects set to receive OSA treatment in the local area
- Ages
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3 to 12 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Male or female, aged \>=3 and \<13 years 2. For NORM group: Children without OSA (AHI\<2) 3. For OSA group: Children with OSA (AHI\>=2) EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Children \<3 years or \>=13 years 2. Any chronic or acute medical condition that in the opinion of the investigators will interfere with overnight sleep study acquisition. 3. Any head injuries or physical conditions that in the opinion of the investigators would affect probe signal and contact. 4. For NORM group: Children with AHI\>=2 5. For OSA group: Children with AHI\<2
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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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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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