Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing

NCT07581938 | Not Yet Recruiting FDA Device

• 1 other identifier: 25-3218
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Pediatric Sleep Questionnaire; Apnea; Obstructive Sleep Apnea (OSA); Sleep Disordered Breathing (SDB); Pediatric Dentistry; At-Home Sleep Study; Pediatric; Screening; Lateral Ceph

Outcome Measures

Primary Outcomes (10)

• Apnea-Hypopnea Index at 4% Desaturation, Total (events/hour)

  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).

  From enrollment to the final study visit at 3 weeks

• Apnea-Hypopnea Index at 3% Desaturation, Total (events/hour)

  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).

  From enrollment to the final study visit at 3 weeks

• Apnea-Hypopnea Index at 4% Desaturation, Obstructive (events/hour)

  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).

  From enrollment to the final study visit at 3 weeks

• Apnea-Hypopnea Index at 3% Desaturation, Obstructive (events/hour)

  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).

  From enrollment to the final study visit at 3 weeks

• Apnea-Hypopnea Index at 4% Desaturation, Central (events/hour)

  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).

  From enrollment to the final study visit at 3 weeks

• Apnea-Hypopnea Index at 3% Desaturation, Central (events/hour)

  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).

  From enrollment to the final study visit at 3 weeks

• Sleep Apnea Indicator

  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 and is reported on a scale of 0 - 100. 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.

  From enrollment to the final study visit at 3 weeks

• Respiratory Disturbance Index at 4% Desaturation

  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.

  From enrollment to the final study visit at 3 weeks

• Respiratory Disturbance Index at 3% Desaturation

  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.

  From enrollment to the final study visit at 3 weeks

• Sleep Quality Index

  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.

  From enrollment to the final study visit at 3 weeks

Secondary Outcomes (6)

• Body Mass Index (BMI)

  At enrollment

• Mallampati Score

  At enrollment

• Brodsky Score

  At enrollment

• Revised Children's Anxiety and Depression Scale- Short (RCADS-25) Score

  At enrollment

• Perceived Stress Scale- Children (PSS- C) Score

  At enrollment

Study Arms (2)

Cohort A

High Risk; Pediatric Sleep Questionnaire \> or = 0.33

Device: SleepImage Ring

Cohort B

Low Risk; Pediatric Sleep Questionnaire \< 0.33

Device: SleepImage Ring

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.

Cohort A; Cohort B

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll children aged 8-13 years receiving care at the University of North Carolina Adams School of Dentistry Pediatric Dentistry Clinic. Participants will be classified into low-risk or high-risk groups for sleep-disordered breathing based on parent-reported Pediatric Sleep Questionnaire scores (\<0.33 vs ≥0.33).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Adams School of Dentistry

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Parker Norman, DMD, ML

  University of North Carolina Adam's School of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Parker Norman, DMD, ML

CONTACT

919-537-3956; parkern@ad.unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)