RecruitingNCT07581938

Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing


Sponsor

University of North Carolina, Chapel Hill

Enrollment

60 participants

Start Date

Jun 1, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 8 YearsMax Age: 13 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called SleepImage Ring for people with early risk screening for sleep disordered breathing in a dental setting, obstructive sleep apnea (osa), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 8 Years to 13 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESleepImage Ring

Objective physiologic sleep measures will be obtained from a wearable home monitor sent home with patients in a pediatric dentistry setting.


Locations(1)

UNC Adams School of Dentistry

Chapel Hill, North Carolina, United States

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NCT07581938


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