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NCT07581938
Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing
Conditions: Early Risk Screening for Sleep Disordered Breathing in a Dental Setting, Sleep Disordered Breathing (SDB), Obstructive Sleep Apnea (OSA)
Sex: All
Ages: 8 Years – 13 Years
Healthy volunteers: Yes
Enrollment: 60
Sponsor: University of North Carolina, Chapel Hill
Location: UNC Adams School of Dentistry Chapel Hill North Carolina
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07581938). StuddyBuddy aggregates publicly available trial information.