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

NCT05052216 | Recruiting

• 2 other identifiers: 10000224000224-CH
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• ScO2, StO2

  peripheral tissue oxygen saturation (StO2), traditional polysomnography measures (SpO2, respiratory effort)

  Baseline

Study Arms (2)

NORM

healthy children

OSA

children with obstructive sleep apnea

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

subjects enrolled in other sleep studies, subjects set to receive OSA treatment in the local area

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Male or female, aged \>=3 and \<13 years
• For NORM group: Children without OSA (AHI\<2)
• For OSA group: Children with OSA (AHI\>=2)

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Children \<3 years or \>=13 years
• Any chronic or acute medical condition that in the opinion of the investigators will interfere with overnight sleep study acquisition.
• 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\>=2
• For OSA group: Children with AHI\<2

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (2)

• Ullman N, Anas NG, Izaguirre E, Haugen W, Ortiz H, Arguello O, Nickerson B, Mink RB. Usefulness of cerebral NIRS in detecting the effects of pediatric sleep apnea. Pediatr Pulmonol. 2014 Oct;49(10):1036-42. doi: 10.1002/ppul.22962. Epub 2013 Dec 11.

  PMID: 24339172 BACKGROUND

• Summerfelt ST, Selosse EJ, Reilly PJ, Trahanovsky WS. 1H-nuclear magnetic resonance spectroscopy of reducing-residue anomeric protons of pertrifluoroacetylated carbohydrates. Carbohydr Res. 1990 Aug 15;203(2):163-72. doi: 10.1016/0008-6215(90)80014-t.

  PMID: 2276122 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Bruce J Tromberg

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thien T Nguyen

CONTACT

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

Bruce J Tromberg

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 22, 2021
• Study Start: August 25, 2022
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-03-13

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)