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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NCT05052216

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 3–12 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
120
US sites recruiting
1
Study start
August 25, 2022
Record last updated
October 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria
  • INCLUSION CRITERIA:

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)

EXCLUSION CRITERIA

An individual who meets any of the following criteria will be excluded from participation in this study:

  • 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
  • For OSA group: Children with AHI\<2

Recruiting US locations

  • National Institutes of Health Clinical Center

    Bethesda, MD 20892

    Site contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · 800-411-1222 · prpl@cc.nih.gov

Study contacts (from the official record)

  • Thien T Nguyen · (301) 814-7234 · thien.nguyen4@nih.gov
  • Bruce J Tromberg · (301) 496-8859 · bruce.tromberg@nih.gov
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