NCT07581938From ClinicalTrials.govRecruiting

Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing

Early Risk Screening for Sleep Disordered Breathing in a Dental Setting
Sleep Disordered Breathing (SDB)
Obstructive Sleep Apnea (OSA)

At a glance

Phase: Phase not stated
Study type: Observational
Sponsor: University of North Carolina, Chapel Hill
Enrolment target: 60
Started: 2 June 2026
Main results due: May 2027
Study sites: 1
Registry updated: 23 September 2026

Can you take part?

Ages 8 years to 13 years.
Open to any sex.
Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

UNC Adams School of Dentistry
Chapel Hill, North Carolina, United States
Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07581938. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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