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

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ClinicalTrials.gov Identifier: NCT05052216
Recruitment Status : Recruiting
First Posted : September 22, 2021
Last Update Posted : August 11, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )

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 3-8 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.


Condition or disease
Pediatric Obstructive Sleep Apnea

Detailed Description:
This observational study will investigate the feasibility of near-infrared spectroscopy (NIRS) for the monitoring of pediatric obstructive sleep apnea (POSA). NIRS can provide a direct examination of brain oxygen saturation that traditional sleep study measurements are not able to capture and may be capable of better explaining health outcomes related to this disease. The purpose of this study is to characterize a wearable, point-of-care NIRS device that measures multiple physiological signals with a focus on cerebral and peripheral oxygenation in children with obstructive sleep apnea and to establish the relationship between traditionally measured parameters during sleep studies (polysomnography) and NIRS technologies. This study will be conducted in collaboration with the Sleep and Neurodevelopment Service at the NIH Clinical Center. Care will not be altered for any patients and this study will be purely observational with no significant risk added to any patient. We hypothesize that NIRS measurements of cerebral and peripheral tissue oxygenation will correlate with respiratory flow and oxygen saturation measured with PSG.

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Study Type : Observational
Estimated Enrollment : 47 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Estimated Study Start Date : August 16, 2022
Estimated Primary Completion Date : January 31, 2026
Estimated Study Completion Date : January 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort
NORM
healthy children
OSA
children with obstructive sleep apnea



Primary Outcome Measures :
  1. ScO2, StO2 [ Time Frame: Baseline ]
    Cerebral and peripheral oxygen saturation



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
subjects enrolled in other sleep studies, subjects set to receive OSA treatment in the local area
Criteria
  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Male or female, aged 3 to 8 years
  • For NORM group: Children without OSA (AHI<1)
  • For OSA group: Children with OSA (AHI>=5)

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Children <3 years or >8 years
  • Any chronic or acute medical condition severe enough to interfere with overnight sleep study acquisition.
  • Taking any medications that are known to change sleep parameters within 2 weeks of screening polysomnogram.
  • 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>1
  • For OSA group: Children with AHI<5

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05052216


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

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Bruce J Tromberg Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Additional Information:
Publications:
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Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT05052216    
Other Study ID Numbers: 10000224
000224-CH
First Posted: September 22, 2021    Key Record Dates
Last Update Posted: August 11, 2022
Last Verified: July 26, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: .Not a clinical trial. This study serves as a pilot to evaluate and characterize a portable NIRS device for sleep research.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
near-infrared spectroscopy (NIRS)
tissue oxygenation
Polysomnography
Natural History
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases