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Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing

2 juni 2026 bijgewerkt door: University of North Carolina, Chapel Hill
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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This study is a prospective, cross-sectional, single-site observational cohort study conducted in a pediatric dental clinic setting. Children aged 8-13 years receiving care at the University of North Carolina Adams School of Dentistry Pediatric Dentistry Clinic will be screened for SDB risk using the PSQ and classified into low-risk or high-risk groups based on established PSQ scoring thresholds.

Following eligibility confirmation and informed consent/assent, enrolled participants will complete all study procedures over a period of up to three weeks. Group classification is determined at enrollment and no randomization, intervention, or treatment assignment occurs.

All participants will complete baseline assessments at Visit 1 (week 0), which will occur either immediately before or immediately after their scheduled dental appointment. Baseline assessments include validated psychosocial questionnaires, vitals (height, weight), and airway assessments (Mallampati and Brodsky scores). Participants will then be provided with a wearable home sleep monitoring ring and instructed to wear the device during sleep for a minimum of three consecutive nights over a period of up to three weeks. The three-week window is included to allow flexibility for scheduling, missed nights, or device return delays, which can occur in pediatric studies despite the low burden of the wearable device. Despite this, participants will be instructed to wear the device for three consecutive nights whenever possible, with the extended window used only as a contingency to ensure complete data collection.

Objective physiologic sleep data will be collected passively through the wearable monitoring device and transmitted via a secure, HIPAA-compliant platform. Study staff will conduct brief adherence check-in phone calls at approximately one and two weeks after device distribution to support compliance and address technical questions. No study-related procedures occur during these calls beyond adherence monitoring.

Study participation will conclude at Visit 2 (week 3), during which the wearable device will be returned, and study staff will assess for any adverse events or participant concerns. Participants identified as high risk for SDB based on screening and physiologic indicators will be provided with standard referral information for further clinical evaluation, consistent with routine clinical care. No diagnostic determinations or therapeutic interventions are delivered as part of this study.

A clinically obtained lateral cephalometric radiograph within six months prior to or within 6 months after the baseline study visit or enrollment will be used when available in the electronic medical record. The radiograph closest to the baseline visit or time of enrollment will be selected for evaluation if multiple radiographs are clinically available.

This observational design allows for evaluation of the agreement of PSQ-based SDB risk classification (high vs low) and objective physiological sleep measures in a pediatric dental setting (Aim 1), BMI and airway assessment correlates of SDB risk (Aim 2), psychosocial correlates of SDB risk (Aim 3), and exploratory analysis of craniofacial features associated with SDB risk classification (Aim 4).

Studietype

Observationeel

Inschrijving (Geschat)

60

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27514
        • Werving
        • UNC Adams School of Dentistry
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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).

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Cohort A
High Risk; Pediatric Sleep Questionnaire > or = 0.33
Apparaat: SleepImage Ring
Objective physiologic sleep measures will be obtained from a wearable home monitor sent home with patients in a pediatric dentistry setting.
Cohort B
Low Risk; Pediatric Sleep Questionnaire < 0.33
Apparaat: SleepImage Ring
Objective physiologic sleep measures will be obtained from a wearable home monitor sent home with patients in a pediatric dentistry setting.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Apnea-Hypopnea Index at 4% Desaturation, Total (events/hour)
Tijdsspanne: 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).
From enrollment to the final study visit at 3 weeks
Apnea-Hypopnea Index at 3% Desaturation, Total (events/hour)
Tijdsspanne: 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).
From enrollment to the final study visit at 3 weeks
Apnea-Hypopnea Index at 4% Desaturation, Obstructive (events/hour)
Tijdsspanne: 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).
From enrollment to the final study visit at 3 weeks
Apnea-Hypopnea Index at 3% Desaturation, Obstructive (events/hour)
Tijdsspanne: 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).
From enrollment to the final study visit at 3 weeks
Apnea-Hypopnea Index at 4% Desaturation, Central (events/hour)
Tijdsspanne: 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).
From enrollment to the final study visit at 3 weeks
Apnea-Hypopnea Index at 3% Desaturation, Central (events/hour)
Tijdsspanne: 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).
From enrollment to the final study visit at 3 weeks
Respiratory Disturbance Index at 4% Desaturation
Tijdsspanne: 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.
From enrollment to the final study visit at 3 weeks
Respiratory Disturbance Index at 3% Desaturation
Tijdsspanne: 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.
From enrollment to the final study visit at 3 weeks
Sleep Quality Index
Tijdsspanne: 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.
From enrollment to the final study visit at 3 weeks
Sleep Apnea Indicator
Tijdsspanne: 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.
From enrollment to the final study visit at 3 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Body Mass Index (BMI)
Tijdsspanne: At enrollment
BMI is a person's weight in kilograms divided by the square of height in meters. For children and teens, BMI is interpreted using sex-specific BMI-for-age percentiles. Underweight is less than the 5th percentile. Healthy weight is the 5th percentile to less than the 85th percentile. Overweight is 85th percentile to less than the 95th percentile. Obesity is the 95th percentile or greater. Severe obesity is 120% of the 95th percentile or greater, or 35 kg/m^2 or greater. Severe obesity can be separated into Class 2 (120% to less than 140% of the 95th percentile, or BMI 35 kg/m^2 to less than 40 kg/m^2) or Class 3 (140% of the 95th percentile or greater, or BMI 40 kg/m^2 or greater).
At enrollment
Mallampati Score
Tijdsspanne: At enrollment
Mallampati Score will be classified from I-IV. Class I: The soft palate, uvula, fauces, and pillars are completely visible. Class II: The soft palate, major part of the uvula, and fauces are visible. Class III: The soft palate and base of the uvula are visible. Class IV: Only the hard palate is visible.
At enrollment
Brodsky Score
Tijdsspanne: At enrollment
The Brodsky Tonsil Grading System uses scares from 0-4. Grade 0: Tonsils are entirely within the tonsillar fossa. Grade 1: Tonsils occupy <25% of the oropharyngeal width. Grade 2: Tonsils occupy 26-50% of the oropharyngeal width. Grade 3: Tonsils occupy 51-75% of the oropharyngeal width. Grade 4: Tonsils occupy >75% of the oropharyngeal width.
At enrollment
Revised Children's Anxiety and Depression Scale- Short (RCADS-25) Score
Tijdsspanne: At enrollment
Revised Children's Anxiety and Depression Scale- Short (RCADS-25) will be completed by pediatric participants and a score from 0-75 will be calculated. Each item is assigned a numerical value: 0 = Never, 1 = Sometimes, 2 = Often, 3 = Always. Anxiety Subscale score is the sum of the numerical values for items 2, 3, 5, 6, 7, 9, 11, 12, 14, 17, 18, 20, 22, 23, 25. Depression Subscale score is the sum of the numerical values for items 1, 4, 8, 10, 13, 15, 16, 19, 21, 24. Total Anxiety and Depression Score is the sum of all 25 items. Raw score corresponds to a T-score from the appropriate grade level chart. Higher scores reflect increased anxiety and depression symptoms.
At enrollment
Perceived Stress Scale- Children (PSS- C) Score
Tijdsspanne: At enrollment
Perceived Stress Scale- Children (PSS- C) will be completed by pediatric participants and a score from 0-39 using the sum of all 13 items will be calculated. Responses are scored on a 4-point Likert scale depending on the question. Each negative item (1, 3, 4, 7, 8, 11) is assigned a standard numerical value: 0 = Never, 1 = A Little, 2 = Sometimes, 3 = A Lot. Each positive item (2, 5, 6, 9, 10, 12, 13) is reverse scored: 3 = Never, 2 = A Little, 1 = Sometimes, 0 = A Lot. Higher scores reflect greater subjective perceived stress. A score of 0-13 reflects low stress where the child perceives low levels of stress in their daily life. A score of 14-26 reflects moderate stress where the child is experiencing a manageable but noticeable level of stress. A score of 27-39 reflects high stress where the child perceives high levels of stress, which may impact school or health.
At enrollment
Children's Report of Sleep Patterns (CRSP) Sleepiness Scale Score
Tijdsspanne: At enrollment
Children's Report of Sleep Patterns (CRSP) Sleepiness Scale will be completed by pediatric participants. The Sleepiness Scale score ranges from 5 to 25 and is calculated as the mean of all completed items, consistent with the original validation study. Responses are scored on a 5-point Likert scale depending on the question, where 1 = Never, 2 = Not very often, 3 = Sometimes, 4 = Usually, and 5 = Always. Higher scores reflect greater subjective daytime sleepiness.
At enrollment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of North Carolina, Chapel Hill

Onderzoekers

  • Hoofdonderzoeker: Parker Norman, DMD, ML, University of North Carolina Adam's School of Dentistry

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 mei 2027

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

5 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 mei 2026

Eerst geplaatst (Werkelijk)

12 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 25-3218

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD-tijdsbestek voor delen

beginning 9 and continuing for 36 months following publication

IPD-toegangscriteria voor delen

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Bestudeer gegevens/documenten

  1. Introduction to SleepImage

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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