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

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT05052216

Collaborator

(none)

Enrollment

Location

41.1

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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

Anticipated Study Start Date :

Aug 30, 2022

Anticipated Primary Completion Date :

Jan 31, 2026

Anticipated Study Completion Date :

Jan 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
NORM healthy children
OSA children with obstructive sleep apnea

Outcome Measures

Primary Outcome Measures

ScO2, StO2 [Baseline]
Cerebral and peripheral oxygen saturation

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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