Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing
2. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Postavení
Nábor
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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).
Typ studie
Typ studie
Pozorovací
Zápis (Odhadovaný)
Zápis
60
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
Studijní kontakt
- Jméno: Parker Norman, DMD, ML
- Telefonní číslo: 919-537-3956
- E-mail: parkern@ad.unc.edu
Studijní místa
-
-
North Carolina
-
Chapel Hill, North Carolina, Spojené státy, 27514
- Nábor
- UNC Adams School of Dentistry
-
Kontakt:
- Parker Norman, DMD, ML
- Telefonní číslo: 919-537-3956
- E-mail: parkern@ad.unc.edu
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Ano
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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).
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Počet skupin / kohort
2
Kohorty a intervence
Skupina / kohortaSkupina / kohorta |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Cohort A
High Risk; Pediatric Sleep Questionnaire > or = 0.33
|
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
|
Objective physiologic sleep measures will be obtained from a wearable home monitor sent home with patients in a pediatric dentistry setting.
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Apnea-Hypopnea Index at 4% Desaturation, Total (events/hour)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Body Mass Index (BMI)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Parker Norman, DMD, ML, University of North Carolina Adam's School of Dentistry
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
Začátek studia
1. června 2026
Primární dokončení (Odhadovaný)
Primární dokončení
1. května 2027
Dokončení studie (Odhadovaný)
Dokončení studie
1. května 2027
Termíny zápisu do studia
První předloženo
První předloženo
5. května 2026
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
5. května 2026
První zveřejněno (Aktuální)
První zveřejněno
12. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
4. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
2. června 2026
Naposledy ověřeno
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 25-3218
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu 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.
Časový rámec sdílení IPD
beginning 9 and continuing for 36 months following publication
Kritéria přístupu pro sdílení IPD
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
Studijní data/dokumenty
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ano
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .