Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-13
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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).

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • SleepImage Ring

    Device

    Objective physiologic sleep measures will be obtained from a wearable home monitor sent home with patients in a pediatric dentistry setting.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Cohort A1 intervention
Group B: Cohort B1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
From enrollment to the final study visit at 3 weeks
2

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).

Time frame
From enrollment to the final study visit at 3 weeks
3

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).

Time frame
From enrollment to the final study visit at 3 weeks
4

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).

Time frame
From enrollment to the final study visit at 3 weeks

Secondary outcomes

1

Body Mass Index (BMI)

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).

Time frame
At enrollment
2

Mallampati Score

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.

Time frame
At enrollment
3

Brodsky Score

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.

Time frame
At enrollment
4

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

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.

Time frame
At enrollment

Other outcomes

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