Recruiting

Observational Study

Sponsor:

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

Code:

NCT05052216

Conditions

Pediatric Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 3 - 12

Healthy Volunteers: Accepted

Study Details

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 3-12 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.

Conditions

Pediatric Obstructive Sleep Apnea

Study ID

NCT05052216

Start date

Aug 25, 2022

Status verified date

Jul 17, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 12

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

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

1. Male or female, aged >=3 and <13 years
2. For NORM group: Children without OSA (AHI<2)
3. For OSA group: Children with OSA (AHI>=2)

EXCLUSION CRITERIA:

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

1. Children <3 years or >=13 years
2. Any chronic or acute medical condition that in the opinion of the investigators will interfere with overnight sleep study acquisition.
3. Any head injuries or physical conditions that in the opinion of the investigators would affect probe signal and contact.
4. For NORM group: Children with AHI>=2
5. For OSA group: Children with AHI<2

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

NORM

healthy children

OSA

children with obstructive sleep apnea

Primary outcome measure

  • ScO2, StO2 [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Thien T Nguyen

(301) 814-7234thien.nguyen4@nih.gov

Bruce J Tromberg

(301) 496-8859bruce.tromberg@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

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

Last update posted

Aug 13, 2026

Last verified

Jul 17, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on 2026-08-13.