Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT05052216|
Recruitment Status : Recruiting
First Posted : September 22, 2021
Last Update Posted : August 11, 2022
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.
To learn about oxygen levels in the brain and limbs in children with and without sleep apnea using a wearable, point-of-care biosensor.
Children aged 3-8 who have OSA and plan to receive treatment (OSA group) or who do not have OSA (NORM group).
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.
|Condition or disease|
|Pediatric Obstructive Sleep Apnea|
|Study Type :||Observational|
|Estimated Enrollment :||47 participants|
|Official Title:||Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea|
|Estimated Study Start Date :||August 16, 2022|
|Estimated Primary Completion Date :||January 31, 2026|
|Estimated Study Completion Date :||January 31, 2026|
children with obstructive sleep apnea
- ScO2, StO2 [ Time Frame: Baseline ]Cerebral and peripheral oxygen saturation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05052216
|Contact: Brian Y Hill||(301) email@example.com|
|Contact: Bruce J Tromberg||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Bruce J Tromberg||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|