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

Recruiting now

Conditions studied: Pediatric Obstructive Sleep Apnea

In brief

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 start treatment for their sleep apnea. They will repeat the sleep study....

Key facts

Study ID

NCT05052216

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

120

Starts

2022-08-25

Expected to finish

2028-01-31

Last updated by the study team

2026-08-07

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Children <3 years or >=13 years
• Any chronic or acute medical condition that in the opinion of the investigators will interfere with overnight sleep study acquisition.
• Any head injuries or physical conditions that in the opinion of the investigators would affect probe signal and contact.
• For NORM group: Children with AHI>=2
• For OSA group: Children with AHI<2

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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