Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
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| ClinicalTrials.gov Identifier: NCT05052216 |
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Recruitment Status :
Recruiting
First Posted : September 22, 2021
Last Update Posted : August 11, 2022
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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 |
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| Pediatric Obstructive Sleep Apnea |
| 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 |
| Group/Cohort |
|---|
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NORM
healthy children
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OSA
children with obstructive sleep apnea
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- ScO2, StO2 [ Time Frame: Baseline ]Cerebral and peripheral oxygen saturation
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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 |
- 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
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
| Contact: Brian Y Hill | (301) 827-0083 | brian.hill@nih.gov | |
| Contact: Bruce J Tromberg | (301) 496-8859 | bruce.tromberg@nih.gov |
| 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 | |
| Principal Investigator: | Bruce J Tromberg | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Publications:
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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near-infrared spectroscopy (NIRS) tissue oxygenation Polysomnography Natural History |
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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 |