Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing
Purpose
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.
Conditions
- Early Risk Screening for Sleep Disordered Breathing in a Dental Setting
- Sleep Disordered Breathing (SDB)
- Obstructive Sleep Apnea (OSA)
Eligibility
- Eligible Ages
- Between 8 Years and 13 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Cohort A | High Risk; Pediatric Sleep Questionnaire > or = 0.33 |
|
| Cohort B | Low Risk; Pediatric Sleep Questionnaire < 0.33 |
|
Recruiting Locations
Chapel Hill, North Carolina 27514
More Details
- Status
- Recruiting
- Sponsor
- University of North Carolina, Chapel Hill
Detailed Description
This study is a prospective, cross-sectional, single-site observational cohort study conducted in a pediatric dental clinic setting. Children aged 8-13 years receiving care at the University of North Carolina Adams School of Dentistry Pediatric Dentistry Clinic will be screened for SDB risk using the PSQ and classified into low-risk or high-risk groups based on established PSQ scoring thresholds. Following eligibility confirmation and informed consent/assent, enrolled participants will complete all study procedures over a period of up to three weeks. Group classification is determined at enrollment and no randomization, intervention, or treatment assignment occurs. All participants will complete baseline assessments at Visit 1 (week 0), which will occur either immediately before or immediately after their scheduled dental appointment. Baseline assessments include validated psychosocial questionnaires, vitals (height, weight), and airway assessments (Mallampati and Brodsky scores). Participants will then be provided with a wearable home sleep monitoring ring and instructed to wear the device during sleep for a minimum of three consecutive nights over a period of up to three weeks. The three-week window is included to allow flexibility for scheduling, missed nights, or device return delays, which can occur in pediatric studies despite the low burden of the wearable device. Despite this, participants will be instructed to wear the device for three consecutive nights whenever possible, with the extended window used only as a contingency to ensure complete data collection. Objective physiologic sleep data will be collected passively through the wearable monitoring device and transmitted via a secure, HIPAA-compliant platform. Study staff will conduct brief adherence check-in phone calls at approximately one and two weeks after device distribution to support compliance and address technical questions. No study-related procedures occur during these calls beyond adherence monitoring. Study participation will conclude at Visit 2 (week 3), during which the wearable device will be returned, and study staff will assess for any adverse events or participant concerns. Participants identified as high risk for SDB based on screening and physiologic indicators will be provided with standard referral information for further clinical evaluation, consistent with routine clinical care. No diagnostic determinations or therapeutic interventions are delivered as part of this study. A clinically obtained lateral cephalometric radiograph within six months prior to or within 6 months after the baseline study visit or enrollment will be used when available in the electronic medical record. The radiograph closest to the baseline visit or time of enrollment will be selected for evaluation if multiple radiographs are clinically available. This observational design allows for evaluation of the agreement of PSQ-based SDB risk classification (high vs low) and objective physiological sleep measures in a pediatric dental setting (Aim 1), BMI and airway assessment correlates of SDB risk (Aim 2), psychosocial correlates of SDB risk (Aim 3), and exploratory analysis of craniofacial features associated with SDB risk classification (Aim 4).