← Back to all trials
Recruiting
NCT05052216
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Conditions: Pediatric Obstructive Sleep Apnea
Sex: All
Ages: 3 Years – 12 Years
Healthy volunteers: Yes
Enrollment: 120
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Location: National Institutes of Health Clinical Center Bethesda Maryland
Summary
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.
Eligibility Criteria
* 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 \=2
5. For OSA group: Children with AHI\
Source: ClinicalTrials.gov (NCT05052216). StuddyBuddy aggregates publicly available trial information.