Actively Recruiting
Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing
Led by University of North Carolina, Chapel Hill · Updated on 2026-06-04
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Pediatric Sleep Questionnaire (PSQ) as a screening tool for identifying children aged 8 to 13 years who may be at risk for sleep-disordered breathing (SDB) in a pediatric dental setting. This observational study aims to compare PSQ risk classifications with physiological sleep data obtained from a wearable, FDA-cleared home sleep monitoring device, as well as psychosocial assessments and craniofacial measurements from lateral cephalometric radiographs. Participants will be classified as either low-risk or high-risk for SDB based on their PSQ scores. After enrollment and consent, children will undergo baseline assessments including psychosocial questionnaires, vital measurements, and airway evaluations. They will then receive a wearable SleepImage Ring device to monitor sleep physiology at home for three consecutive nights within a three-week period. The study includes follow-up calls to support device use and concludes with a return visit to collect the device and review any concerns. Throughout the study, researchers will collect objective sleep data through the wearable device, psychosocial questionnaires, and craniofacial imaging when available. The main outcomes measured include various apnea-hypopnea indexes and sleep quality indices over the three weeks. Participants identified as high risk will be offered referral information for further clinical evaluation, but no treatment or diagnostic interventions are provided as part of the study.
CONDITIONS
Brief Title
Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 8 to 13 years old
- American Society of Anesthesiologists Class I or II
- Ability to read and understand English or Spanish
- Ability to assent, with parent or legal guardian able to provide informed consent
- Access to a smartphone capable of supporting the wearable monitoring application
You will not qualify if you...
- Diagnosis of a craniofacial syndrome or condition that significantly alters craniofacial morphology
- Prior diagnosis of sleep disordered breathing or obstructive sleep apnea
- History of adenotonsillectomy
- Prior or current orthodontic treatment
- Prior orthognathic surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 3 weeks
Participants wear a home sleep monitoring ring during sleep for a minimum of three consecutive nights to collect objective physiologic sleep data passively.
Wearable device worn at home for 3 nights within a 3-week window, with 2 brief adherence check-in phone calls
Duration - 1 day
Participants return the wearable device and study staff assess for any adverse events or participant concerns. Participants identified as high risk for sleep-disordered breathing will receive referral information for further clinical evaluation.
1 in-person visit to return the device and complete study procedures
Trial Site Locations
Total: 1 location
1
UNC Adams School of Dentistry
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
Research Team
P
Parker Norman, DMD, ML
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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