Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-13
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SleepImage Ring

Treatment groups

60 Participants
are divided into 2 treatment groups