Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sleep Apnea Indicator
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cohort B
Low Risk; Pediatric Sleep Questionnaire < 0.33
干预措施: SleepImage Ring (Device)
Cohort A
High Risk; Pediatric Sleep Questionnaire > or = 0.33
干预措施: SleepImage Ring (Device)
结局指标
主要结局
Sleep Apnea Indicator
时间窗: 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.
Apnea-Hypopnea Index at 4% Desaturation, Total (events/hour)
时间窗: 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).
Apnea-Hypopnea Index at 3% Desaturation, Total (events/hour)
时间窗: 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).
Apnea-Hypopnea Index at 4% Desaturation, Obstructive (events/hour)
时间窗: 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).
Apnea-Hypopnea Index at 3% Desaturation, Obstructive (events/hour)
时间窗: 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).
Apnea-Hypopnea Index at 4% Desaturation, Central (events/hour)
时间窗: 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).
Apnea-Hypopnea Index at 3% Desaturation, Central (events/hour)
时间窗: 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).
Respiratory Disturbance Index at 4% Desaturation
时间窗: 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.
Respiratory Disturbance Index at 3% Desaturation
时间窗: 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.
Sleep Quality Index
时间窗: 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.
次要结局
- Body Mass Index (BMI)(At enrollment)
- Mallampati Score(At enrollment)
- Brodsky Score(At enrollment)
- Revised Children's Anxiety and Depression Scale- Short (RCADS-25) Score(At enrollment)
- Perceived Stress Scale- Children (PSS- C) Score(At enrollment)
- Children's Report of Sleep Patterns (CRSP) Sleepiness Scale Score(At enrollment)