Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
- Pediatric Obstructive Sleep Apnea
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Enrolment target
- 120
- Started
- 25 August 2022
- Main results due
- 31 January 2028
- Study sites
- 1
- Registry updated
- 28 September 2026
Can you take part?
- Ages 3 years to 12 years.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Male or female, aged \>=3 and \<13 years 2. For NORM group: Children without OSA (AHI\<2) 3. 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: 1. Children \<3 years or \>=13 years 2. Any chronic or acute medical condition that in the opinion of the investigators will interfere with overnight sleep study acquisition. 3. Any head injuries or physical conditions that in the opinion of the investigators would affect probe signal and contact. 4. For NORM group: Children with AHI\>=2 5. For OSA group: Children with AHI\<2
What this study is about
In the sponsor’s own words, from the registry.
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....
Study sites(1)
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05052216. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me