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Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea

Recruitingn/aAges 3 Years - 12 YearsAllEunice Kennedy Shriver National Institute of Chil…
NCT05052216 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: Obstructive sleep apnea (OSA) occurs when the blockage of the airway causes a person to stop breathing involuntarily for 10 seconds or more throughout the night during sleep. Pediatric OSA can be especially concerning and can have long-term effects. Researchers want to see how a monitoring device called near-infrared spectroscopy (NIRS) compares with the traditional techniques used in children s sleep studies. Objective: To learn about oxygen levels in the brain and limbs in children with and without sleep apnea using a wearable, point-of-care biosensor. Eligibility: Children aged 3-12 who have OSA and plan to receive treatment (OSA group) or who do not have OSA (NORM group). Design: Participants will be screened with a review of their medical records. If they have taken part in other NIH studies, that data will be reviewed as well. Participants in the NORM group will

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📋 Eligibility rules (as published)
* 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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What it tests

  • Not listed
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Where

1 site
National Institutes of Health Clinical Center
Bethesda, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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