NCT05052216 Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
| NCT ID | NCT05052216 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Condition | Pediatric Obstructive Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-08-25 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2022-08-25 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Bruce J Tromberg
PRINCIPAL INVESTIGATOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Frequently Asked Questions
Who can join the NCT05052216 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 12 Years, studying Pediatric Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05052216 currently recruiting?
Yes, NCT05052216 is actively recruiting participants. Contact the research team at thien.nguyen4@nih.gov for enrollment information.
Where is the NCT05052216 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT05052216 clinical trial?
NCT05052216 is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The principal investigator is Bruce J Tromberg at Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The trial plans to enroll 120 participants.