RECRUITING

Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea

Quick Facts

Study Start:2022-08-25
Study Completion:2026-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05052216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female, aged \>=3 and \<13 years
  2. 2. For NORM group: Children without OSA (AHI\<2)
  3. 3. For OSA group: Children with OSA (AHI\>=2)
  1. 1. Children \<3 years or \>=13 years
  2. 2. Any chronic or acute medical condition that in the opinion of the investigators will interfere with overnight sleep study acquisition.
  3. 3. Any head injuries or physical conditions that in the opinion of the investigators would affect probe signal and contact.
  4. 4. For NORM group: Children with AHI\>=2
  5. 5. For OSA group: Children with AHI\<2

Contacts and Locations

Study Contact

Brian Y Hill
CONTACT
(301) 827-0083
brian.hill@nih.gov
Bruce J Tromberg
CONTACT
(301) 496-8859
bruce.tromberg@nih.gov

Principal Investigator

Bruce J Tromberg
PRINCIPAL_INVESTIGATOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  • Bruce J Tromberg, PRINCIPAL_INVESTIGATOR, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-25
Study Completion Date2026-01-31

Study Record Updates

Study Start Date2022-08-25
Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

  • near-infrared spectroscopy (NIRS)
  • tissue oxygenation
  • Polysomnography
  • Natural History

Additional Relevant MeSH Terms

  • Pediatric Obstructive Sleep Apnea