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Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing

2 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Szacowany)

60

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Stany Zjednoczone
    • North Carolina
      • Chapel Hill, North Carolina, Stany Zjednoczone, 27514
        • Rekrutacyjny
        • UNC Adams School of Dentistry
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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).

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Cohort A
High Risk; Pediatric Sleep Questionnaire > or = 0.33
Urządzenie: 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
Urządzenie: SleepImage Ring
Objective physiologic sleep measures will be obtained from a wearable home monitor sent home with patients in a pediatric dentistry setting.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Apnea-Hypopnea Index at 4% Desaturation, Total (events/hour)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Body Mass Index (BMI)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of North Carolina, Chapel Hill

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 maja 2027

Ukończenie studiów (Szacowany)

1 maja 2027

Daty rejestracji na studia

Pierwszy przesłany

5 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 maja 2026

Pierwszy wysłany (Rzeczywisty)

12 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 25-3218

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania IPD

beginning 9 and continuing for 36 months following publication

Kryteria dostępu do udostępniania IPD

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

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • ICF

Badanie danych/dokumentów

  1. Introduction to SleepImage

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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