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Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing

2 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Osservativo

Iscrizione (Stimato)

60

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27514
        • Reclutamento
        • UNC Adams School of Dentistry
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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).

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Cohort A
High Risk; Pediatric Sleep Questionnaire > or = 0.33
Dispositivo: 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
Dispositivo: SleepImage Ring
Objective physiologic sleep measures will be obtained from a wearable home monitor sent home with patients in a pediatric dentistry setting.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Apnea-Hypopnea Index at 4% Desaturation, Total (events/hour)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Body Mass Index (BMI)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of North Carolina, Chapel Hill

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 maggio 2027

Completamento dello studio (Stimato)

1 maggio 2027

Date di iscrizione allo studio

Primo inviato

5 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 25-3218

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

beginning 9 and continuing for 36 months following publication

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF

Dati/documenti di studio

  1. Introduction to SleepImage

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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