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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 12
Healthy Volunteers: t
View:

⁃ In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Male or female, aged \>=3 and \<13 years

• For NORM group: Children without OSA (AHI\<2)

• For OSA group: Children with OSA (AHI\>=2)

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Brian Y Hill
brian.hill@nih.gov
(301) 827-0083
Backup
Bruce J Tromberg
bruce.tromberg@nih.gov
(301) 496-8859
Time Frame
Start Date: 2022-08-25
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 120
Treatments
NORM
healthy children
OSA
children with obstructive sleep apnea
Related Therapeutic Areas
Sponsors
Leads: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov