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Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing

Who can join

Ages 8 to 13 · All sexes · Healthy volunteers welcome

Inclusion Criteria:

* Ages 8-13 years old
* American Society of Anesthesiologists Class I or II
* Ability to read and understand the English or Spanish language
* Ability to assent, with parent/legal guardian able to provide informed consent
* Access to a smartphone capable of supporting the wearable monitoring application

Exclusion Criteria:

* Diagnosis of a craniofacial syndrome or condition known to significantly alter craniofacial morphology
* Prior diagnosis of sleep disordered breathing and/or obstructive sleep apnea
* History of adenotonsillectomy
* Prior or current orthodontic treatment
* Prior orthognathic surgery

About the study

This is a prospective, cross-sectional observational study designed to evaluate the Pediatric Sleep Questionnaire (PSQ) as a screening tool for sleep-disordered breathing (SDB) risk in a pediatric dental setting. Children aged 8-13 years will be classified as low- or high-risk for SDB based on PSQ scores and compared using physiologic sleep parameters obtained from a wearable, FDA-cleared home sleep monitoring device, alongside psychosocial assessments and craniofacial measurements derived from lateral cephalometric radiographs. Findings will inform the feasibility and accuracy of incorporating validated SDB screening into routine pediatric dental care.

What is being tested

• SleepImage Ring (device)

Sponsor: University of North Carolina, Chapel Hill · Participants: 60 · Started: Jun 2, 2026

Contact the study team

• Parker Norman, DMD, ML · Phone: 919-537-3956

Official record on ClinicalTrials.gov — NCT07581938

Locations in the U.S.

Conditions

• Sleep Apnea
• Obstructive Sleep Apnea
• Apnea

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.