Wearable device for monitoring sleep apnea in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate a wearable point-of-care device using near-infrared spectroscopy (NIRS) to monitor oxygen levels in the brain and limbs of children with and without obstructive sleep apnea (OSA). Participants aged 3-12 will be divided into two groups: those diagnosed with OSA and those without. The study will involve overnight monitoring sessions to compare NIRS data with traditional polysomnography measurements. The goal is to better understand the relationship between oxygen saturation and apnea events, potentially leading to improved monitoring techniques for pediatric OSA.

Why it matters

Who can join: the full rules

* 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

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Bruce J Tromberg — Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Study coordinator: Thien T Nguyen
• Email: thien.nguyen4@nih.gov
• Phone: (301) 814-7234

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.