Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07581938
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
8 Years - 13 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Cohort A
    High Risk; Pediatric Sleep Questionnaire \> or = 0.33
  • Arm: Cohort B
    Low Risk; Pediatric Sleep Questionnaire \< 0.33

Primary Outcome Measure

Apnea-Hypopnea Index at 4% Desaturation, Total (events/hour) [ Time Frame: From enrollment to the final study visit at 3 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UNC Adams School of DentistryChapel HillNorth Carolina27514
Parker Norman, DMD, ML
[email protected]
919-537-3956

Find similar trials in Chapel Hill, NC

By research site
UNC Adams School of Dentistry· Chapel Hill, NC

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