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

NCT05052216 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Pediatric Obstructive Sleep Apnea

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Bruce J Tromberg · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-25
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05052216 on ClinicalTrials.gov