Recruiting

Observational Study

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07581938

Conditions

Early Risk Screening for Sleep Disordered Breathing in a Dental Setting

Sleep Disordered Breathing (SDB)

Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex: All

Age: 8 - 13

Healthy Volunteers: Accepted

Interventions

SleepImage Ring

Study Details

Brief summary:

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.

Conditions

Early Risk Screening for Sleep Disordered Breathing in a Dental Setting

Sleep Disordered Breathing (SDB)

Obstructive Sleep Apnea (OSA)

Study ID

NCT07581938

Start date

Jun, 2026

Status verified date

Jun, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 13

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort A

High Risk; Pediatric Sleep Questionnaire > or = 0.33

Cohort B

Low Risk; Pediatric Sleep Questionnaire < 0.33

Interventions

SleepImage Ring

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

Primary outcome measure

  • Apnea-Hypopnea Index at 4% Desaturation, Total (events/hour) [ Time Frame: From enrollment to the final study visit at 3 weeks ]
  • Apnea-Hypopnea Index at 3% Desaturation, Total (events/hour) [ Time Frame: From enrollment to the final study visit at 3 weeks ]
  • Apnea-Hypopnea Index at 4% Desaturation, Obstructive (events/hour) [ Time Frame: From enrollment to the final study visit at 3 weeks ]
  • Apnea-Hypopnea Index at 3% Desaturation, Obstructive (events/hour) [ Time Frame: From enrollment to the final study visit at 3 weeks ]
  • Apnea-Hypopnea Index at 4% Desaturation, Central (events/hour) [ Time Frame: From enrollment to the final study visit at 3 weeks ]
  • Apnea-Hypopnea Index at 3% Desaturation, Central (events/hour) [ Time Frame: From enrollment to the final study visit at 3 weeks ]
  • Sleep Apnea Indicator [ Time Frame: From enrollment to the final study visit at 3 weeks ]
  • Respiratory Disturbance Index at 4% Desaturation [ Time Frame: From enrollment to the final study visit at 3 weeks ]
  • Respiratory Disturbance Index at 3% Desaturation [ Time Frame: From enrollment to the final study visit at 3 weeks ]
  • Sleep Quality Index [ Time Frame: From enrollment to the final study visit at 3 weeks ]

Central Contacts and Locations

Central contacts

Parker Norman, DMD, ML

919-537-3956parkern@ad.unc.edu

Locations

UNC Adams School of Dentistry

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Parker Norman, DMD, ML

919-537-3956parkern@ad.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • Pediatric Sleep Questionnaire
  • Apnea
  • Obstructive Sleep Apnea (OSA)
  • Sleep Disordered Breathing (SDB)
  • Pediatric Dentistry
  • At-Home Sleep Study
  • Pediatric
  • Screening
  • Lateral Ceph

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-06-04.