About this trial
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
This trial accepts healthy volunteersQualifiers
Male or female, aged >=3 and <13 years
For NORM group: Children without OSA (AHI<2)
For OSA group: Children with OSA (AHI>=2)
Disqualifiers
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
Trial population
subjects enrolled in other sleep studies, subjects set to receive OSA treatment in the local area
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
ScO2, StO2
peripheral tissue oxygen saturation (StO2), traditional polysomnography measures (SpO2, respiratory effort)
Sponsors and contacts
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