RecruitingNot Applicable

Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing

United States60 participantsStarted 2026-06

Plain-language 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.

Who can participate

Age range

8 Years – 13 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Apnea-Hypopnea Index at 4% Desaturation, Total (events/hour)

Timeframe: From enrollment to the final study visit at 3 weeks

Apnea-Hypopnea Index at 3% Desaturation, Total (events/hour)

Timeframe: From enrollment to the final study visit at 3 weeks

Apnea-Hypopnea Index at 4% Desaturation, Obstructive (events/hour)

Timeframe: From enrollment to the final study visit at 3 weeks

Apnea-Hypopnea Index at 3% Desaturation, Obstructive (events/hour)

Timeframe: From enrollment to the final study visit at 3 weeks

Apnea-Hypopnea Index at 4% Desaturation, Central (events/hour)

Timeframe: From enrollment to the final study visit at 3 weeks

Apnea-Hypopnea Index at 3% Desaturation, Central (events/hour)

Timeframe: From enrollment to the final study visit at 3 weeks

Sleep Apnea Indicator

Trial details

NCT IDNCT07581938

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-05

Contact for this trial

Parker Norman, DMD, ML

919-537-3956 parkern@ad.unc.edu

View on ClinicalTrials.gov More Early Risk Screening for Sleep Disordered Breathing in a Dental Setting trials