Wearable device for monitoring sleep apnea in children
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
This study is testing a new wearable device to see if it can help monitor oxygen levels in the brains and limbs of children with and without sleep apnea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 3 Years to 12 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05052216 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate a wearable point-of-care device using near-infrared spectroscopy (NIRS) to monitor oxygen levels in the brain and limbs of children with and without obstructive sleep apnea (OSA). Participants aged 3-12 will be divided into two groups: those diagnosed with OSA and those without. The study will involve overnight monitoring sessions to compare NIRS data with traditional polysomnography measurements. The goal is to better understand the relationship between oxygen saturation and apnea events, potentially leading to improved monitoring techniques for pediatric OSA.
Who should consider this trial
Good fit: Ideal candidates are children aged 3-12 who either have obstructive sleep apnea or do not have the condition.
Not a fit: Patients with chronic or acute medical conditions that interfere with sleep studies or those outside the age range of 3-12 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to enhanced monitoring and understanding of pediatric obstructive sleep apnea, improving patient outcomes.
How similar studies have performed: While the use of NIRS in sleep studies is emerging, this specific approach is novel and has not been extensively tested in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Bruce J Tromberg — Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study coordinator: Thien T Nguyen
- Email: thien.nguyen4@nih.gov
- Phone: (301) 814-7234
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.