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Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing

Recruitingn/aAges 8 Years - 13 YearsAllUniversity of North Carolina, Chapel Hill
NCT07581938 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • SleepImage Ring
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Where

1 site
UNC Adams School of Dentistry
Chapel Hill, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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