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NCT07581938 · ClinicalTrials.gov registry record
Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- 60
- Enrollment target
NCT07581938: Recruiting study, sponsored by University of North Carolina, Chapel Hill.
NCT07581938 is a clinical trial that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07581938 is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
Apnea-Hypopnea Index (AHI) is an automated measure of Apnea/Hypopnea events per hour and is FDA-cleared to aid diagnosis of Sleep Disordered Breathing (SDB) in both children and adults following the American Academy of Sleep Medicine (AASM) categorization (mild, moderate, severe). SleepImage values for AHI (sAHI) at 4% desaturation and for total events will be reported. In children, AHI \< 1.0 corresponds to no sleep apnea, AHI 1.0 to \< 5.0 corresponds to mild sleep apnea, AHI 5.0 to \< 10.0 co
Interventions
- DEVICE SleepImage Ring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-06 |
| Est. Completion | 2027-05 |
What NCT07581938 shows while recruiting
NCT07581938 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which SleepImage Ring is the first listed.
NCT07581938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07581938 about?
NCT07581938 is a clinical study titled "Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing". 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 s...
What is the current status of trial NCT07581938?
This trial is currently recruiting. The enrollment target is 60 participants. The study started on 2026-06. Estimated completion is 2027-05.
What interventions are being tested in trial NCT07581938?
The interventions under investigation include: SleepImage Ring (DEVICE).
Who is sponsoring clinical trial NCT07581938?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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