Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea (NCT05052216) | Clinical Trial Compass
RecruitingNot Applicable
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
United States120 participantsStarted 2022-08-25
Plain-language 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.
Who can participate
Age range
3 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ScO2, StO2
Timeframe: Baseline
Trial details
NCT IDNCT05052216
SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)