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Study identifier: NCT05052216 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Pediatric Obstructive Sleep Apnea  ·  Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

PhaseN/A
Planned participants120
Who can joinAll sexes, 3 Years to 12 Years
Healthy volunteersYes

About this study

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 have 1 overnight study visit. Those in the OSA group will have 2 overnight study visits. Participants will do an overnight sleep study. They will have a physical exam and medical history. They will have a sleep study electroencephalography (EEG). For this, electrodes will be placed on their head. They will wear a gauze cap to keep the electrodes in place. Two NIRS probes made of a soft silicon will be placed on their forehead and arm. They will follow their normal bedtime routine. Their parent will stay overnight. The OSA group will have a second study visit 2 weeks to 12 months after they …

This description comes directly from the study's public registry record.

Talk to the study team

Thien T Nguyen  ·  (301) 814-7234  ·  thien.nguyen4@nih.gov

Bruce J Tromberg  ·  (301) 496-8859  ·  bruce.tromberg@nih.gov

Always discuss trial participation with your own doctor first.

Locations (1)

National Institutes of Health Clinical CenterBethesda, Maryland, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05052216