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Early Dental Risk Screening for Pediatric Sleep-Disordered Breathing

2026年6月2日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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).

研究の種類

観察的

入学 (推定)

60

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Parker Norman, DMD, ML
  • 電話番号：919-537-3956
  • メール：parkern@ad.unc.edu

研究場所

  • アメリカ
    • North Carolina
      • Chapel Hill、North Carolina、アメリカ、27514
        • 募集
        • UNC Adams School of Dentistry
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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).

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Cohort A
High Risk; Pediatric Sleep Questionnaire > or = 0.33
デバイス：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
デバイス：SleepImage Ring
Objective physiologic sleep measures will be obtained from a wearable home monitor sent home with patients in a pediatric dentistry setting.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Apnea-Hypopnea Index at 4% Desaturation, Total (events/hour)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Body Mass Index (BMI)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of North Carolina, Chapel Hill

捜査官

  • 主任研究者：Parker Norman, DMD, ML、University of North Carolina Adam's School of Dentistry

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2027年5月1日

研究の完了 (推定)

2027年5月1日

試験登録日

最初に提出

2026年5月5日

QC基準を満たした最初の提出物

2026年5月5日

最初の投稿 (実際)

2026年5月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月4日

QC基準を満たした最後の更新が送信されました

2026年6月2日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 25-3218

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

IPD 共有時間枠

beginning 9 and continuing for 36 months following publication

IPD 共有アクセス基準

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

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • ICF

試験データ・資料

  1. Introduction to SleepImage

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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