Wearable sensor to check brain and arm oxygen in children with sleep apnea
Tests a wearable sensor measuring oxygen during sleep in children with and without sleep apnea.
Key facts
- Who runs it
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Where
- Bethesda, United StatesSee the site
- Trial code
- Registry title
- Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
- Status
- Recruiting
- People taking part
- 120 people, planned
- Started
- 25 Aug 2022
- Expected to end
- 31 Jan 2028
- Type of study
- Observational, 2 groups
- Record updated
- 5 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children with obstructive sleep apnea (breathing stops during sleep) who plan to get treatment, and children without it. It tests a wearable sensor that measures oxygen in the brain and limbs.
- Age
- 3 to 12 years (at least 3 and under 13 years).
- Sex
- Boys and girls.
- Disease stage
- OSA group: obstructive sleep apnea with AHI>=2 (AHI counts breathing pauses per hour of sleep). Comparison group: children without sleep apnea, AHI<2.
- Earlier treatment
- Children in the OSA group plan to start treatment for their sleep apnea.
- Biomarker or test result
- AHI>=2 for the OSA group. AHI<2 for the group without sleep apnea.
Main reasons for not taking part
- Children younger than 3 years or 13 years and older.
- Any long-term or sudden illness that the researchers think would disturb the overnight sleep study.
- Head injuries or physical conditions that the researchers think would affect the sensor signal or contact.
The registry criteria, word for word
Show all 10 criteriaShow less
Who cannot take part
- 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
- Children <3 years or >=13 years
- An individual who meets any of the following criteria will be excluded from participation in this study:
- For NORM group: Children with AHI>=2
- For OSA group: Children with AHI<2
Other 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)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 12 years old?
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesContact: Thien T NguyenTaking people
About the trial
What the trial wants to find out
Background:
Read full original descriptionShow less
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.
The 2 groups in the trial
- NORM
healthy children
- OSA
children with obstructive sleep apnea
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
- Plain-language title
- Wearable sensor to check brain and arm oxygen in children with sleep apneaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT05052216, who can take part
- Record updated
- 5 November 2026