NCT07581938 · University of North Carolina, Chapel Hill
Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing
What this study is about
This is a forward-looking, 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.
View original scientific description
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.
Interventions
DEVICE
SleepImage Ring
Objective physiologic sleep measures will be obtained from a wearable home monitor sent home with patients in a pediatric dentistry setting.
Primary outcome measures
Apnea-Hypopnea Index at 4% Desaturation, Total (events/hour)
Time frame: From enrollment to the final study visit at 3 weeks
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 corresponds to moderate sleep apnea, and AHI of 10 or more corresponds to severe sleep apnea. Scale starts at 0 and has no finite end point. SleepImage measured AHI will be reported (sAHI).
Apnea-Hypopnea Index at 3% Desaturation, Total (events/hour)
Time frame: From enrollment to the final study visit at 3 weeks
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 AASM categorization (mild, moderate, severe). SleepImage values for AHI (sAHI) at 3% 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 corresponds to moderate sleep apnea, and AHI of 10 or more corresponds to severe sleep apnea. Scale starts at 0 and has no finite end point. SleepImage measured AHI will be reported (sAHI).
Apnea-Hypopnea Index at 4% Desaturation, Obstructive (events/hour)
Time frame: From enrollment to the final study visit at 3 weeks
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 AASM categorization (mild, moderate, severe). SleepImage values for AHI (sAHI) at 4% desaturation and for obstructive 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 corresponds to moderate sleep apnea, and AHI of 10 or more corresponds to severe sleep apnea. Scale starts at 0 and has no finite end point. SleepImage measured AHI will be reported (sAHI).
Apnea-Hypopnea Index at 3% Desaturation, Obstructive (events/hour)
Time frame: From enrollment to the final study visit at 3 weeks
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 AASM categorization (mild, moderate, severe). SleepImage values for AHI (sAHI) at 3% desaturation and for obstructive 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 corresponds to moderate sleep apnea, and AHI of 10 or more corresponds to severe sleep apnea. Scale starts at 0 and has no finite end point. SleepImage measured AHI will be reported (sAHI).
Apnea-Hypopnea Index at 4% Desaturation, Central (events/hour)
Time frame: From enrollment to the final study visit at 3 weeks
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 AASM categorization (mild, moderate, severe). SleepImage values for AHI (sAHI) at 4% desaturation and for central 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 corresponds to moderate sleep apnea, and AHI of 10 or more corresponds to severe sleep apnea. Scale starts at 0 and has no finite end point. SleepImage measured AHI will be reported (sAHI).
Apnea-Hypopnea Index at 3% Desaturation, Central (events/hour)
Time frame: From enrollment to the final study visit at 3 weeks
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 AASM categorization (mild, moderate, severe). SleepImage values for AHI (sAHI) at 3% desaturation and for central 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 corresponds to moderate sleep apnea, and AHI of 10 or more corresponds to severe sleep apnea. Scale starts at 0 and has no finite end point. SleepImage measured AHI will be reported (sAHI).
Sleep Apnea Indicator
Time frame: From enrollment to the final study visit at 3 weeks
Sleep apnea indicator (SAI) is based on detecting cardiac reaction associated with prolonged cycles of oxygen desaturation, based on Cyclic Variation of Heart Rate (CVHR) during unstable breathing (tidal volume variability in breathing) during sleep. During each apnea event, blood oxygen decreases and is accompanied by a physiological reaction of bradycardia and, when breathing resumes, a relative tachycardia; hypoxemia is thus reflected in this cardiac response and in the SleepImage output as SAI. It is based on the American Academy of Sleep Medicine's guidelines. It is categorized as mild, moderate, and severe based on threshold markers. In children, \> or = 1 is the cutoff for mild, \> or = 5 is the cutoff for moderate, and \> or = 10 is the cutoff for severe. The scale starts at 0 and has no finite end point.
Respiratory Disturbance Index at 4% Desaturation
Time frame: From enrollment to the final study visit at 3 weeks
The SleepImage measured Respiratory Disturbance Index (sRDI, RDI) includes apnea- and hypopnea events and in addition arousals that are not related to desaturations but may disrupt sleep and cause sleep fragmentation and may therefore provide information for more comprehensive evaluation of respiratory disturbances during sleep. It is categorized as mild, moderate, and severe based on threshold markers. In children, \> or = 1 is the cutoff for mild, \> or = 5 is the cutoff for moderate, and \> or = 10 is the cutoff for severe. The scale starts at 0 and has no finite end point.
Respiratory Disturbance Index at 3% Desaturation
Time frame: From enrollment to the final study visit at 3 weeks
The SleepImage measured Respiratory Disturbance Index (sRDI, RDI) includes apnea- and hypopnea events and in addition arousals that are not related to desaturations but may disrupt sleep and cause sleep fragmentation and may therefore provide information for more comprehensive evaluation of respiratory disturbances during sleep. It is categorized as mild, moderate, and severe based on threshold markers. In children, \> or = 1 is the cutoff for mild, \> or = 5 is the cutoff for moderate, and \> or = 10 is the cutoff for severe. The scale starts at 0 and has no finite end point.
Sleep Quality Index
Time frame: From enrollment to the final study visit at 3 weeks
Sleep Quality Index (SQI) is a summary index of the cardiopulmonary coupling (CPC) biomarkers of sleep quality, sleep stability, fragmentation, and periodicity, which provides a meaningful unit of measure of sleep health. The SQI is displayed on a scale of 0-100 with expected values for children. Greater than 70 is expected for children. 70 or less corresponds to decreased sleep quality.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chapel Hill, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations