NCT07581938 Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing
| NCT ID | NCT07581938 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Early Risk Screening for Sleep Disordered Breathing in a Dental Setting |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-06 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2026-06 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Parker Norman, DMD, ML
PRINCIPAL INVESTIGATOR
University of North Carolina Adam's School of Dentistry
Frequently Asked Questions
Who can join the NCT07581938 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 13 Years, studying Early Risk Screening for Sleep Disordered Breathing in a Dental Setting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07581938 currently recruiting?
Yes, NCT07581938 is actively recruiting participants. Contact the research team at parkern@ad.unc.edu for enrollment information.
Where is the NCT07581938 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT07581938 clinical trial?
NCT07581938 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Parker Norman, DMD, ML at University of North Carolina Adam's School of Dentistry. The trial plans to enroll 60 participants.