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NCT05052216 · ClinicalTrials.gov registry record
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
A clinical trial of Pediatric Obstructive Sleep Apnea, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Recruiting
- Registry status
- 120
- Enrollment target
- 1
- Study location
NCT05052216: Recruiting study of Pediatric Obstructive Sleep Apnea, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT05052216 is a study of Pediatric Obstructive Sleep Apnea that is actively recruiting participants, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 120 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05052216, a study of Pediatric Obstructive Sleep Apnea, is actively recruiting participants, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- RECRUITING
- Registry status
- 120 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
peripheral tissue oxygen saturation (StO2), traditional polysomnography measures (SpO2, respiratory effort)
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-08-25 |
| Est. Completion | 2028-01-31 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What NCT05052216 shows while recruiting
NCT05052216 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Pediatric Obstructive Sleep Apnea appearing as the primary indexed condition, and to 0 interventions.
NCT05052216 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05052216 about?
NCT05052216 is a clinical study titled "Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea". 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 monitor...
What is the current status of trial NCT05052216?
This trial is currently recruiting. The enrollment target is 120 participants. The study started on 2022-08-25. Estimated completion is 2028-01-31.
What conditions does trial NCT05052216 study?
This clinical trial studies the following conditions: Pediatric Obstructive Sleep Apnea.
Who is sponsoring clinical trial NCT05052216?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05052216 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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