What this study is
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.
Study details
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Conditions
- Pediatric Obstructive Sleep Apnea
- Enrolling
- 120 people
- Starts
- 2022-08-25
- Est. completion
- 2028-01-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 3 Years – 12 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Male or female, aged >=3 and <13 years
- For NORM group: Children without OSA (AHI<2)
- For OSA group: Children with OSA (AHI>=2)
You can't join if
- 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.
- For NORM group: Children with AHI>=2
- For OSA group: Children with AHI<2
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNational Institutes of Health Clinical Center
Bethesda, Maryland, United States
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contact800-411-1222 ext. TTY8664111010prpl@cc.nih.gov
Recruiting
Study team
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study ID 10000224
Principal investigator
Bruce J Tromberg
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.