Actively Recruiting
Improving Outcomes in Pediatric Obstructive Sleep Apnea With Computational Fluid Dynamics
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-01-07
120
Participants Needed
1
Research Sites
419 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
To create a validated computational tool to predict surgical outcomes for pediatric patients with obstructive sleep apnea (OSA). The first line of treatment for children with OSA is to remove their tonsils and adenoids; however, these surgeries do not always cure the patient. Another treatment, continuous positive airway pressure (CPAP) is only tolerated by 50% of children. Therefore, many children undergo surgical interventions aimed at soft tissue structures surrounding the airway, such as tonsils, tongue, and soft palate, and/or the bony structures of the face. However, the success rates of these surgeries is surprisingly low. Therefore, there a need for a tool to improve the efficacy and predict which surgical option is going to benefit each individual patient most effectively. Computational fluid dynamics (CFD) simulations of respiratory airflow in the upper airways can provide this predictive tool, allowing the effects of various surgical options to be compared virtually and the option most likely to improve the patient's condition to be chosen. Previous CFD simulations have been unable to provide information about OSA as they were based on rigid geometries, or did not include neuromuscular motion, a key component in OSA. This project uses real-time magnetic resonance imaging (MRI) to provide the anatomy and motion of the airway to the CFD simulation, meaning that the exact in vivo motion is modeled for the first time. Furthermore, since the modeling is based on MRI, a modality which does not use ionizing radiation, it is suitable for longitudinal assessment of patients before and after surgical procedures. In vivo validation of these models will be achieved for the first time through comparison of CFD-based airflow velocity fields with those generated by phase-contrast MRI of inhaled hyperpolarized 129Xe gas. This research is based on data obtained from sleep MRIs achieved with the subject under sedation. While sedating the patient post-operatively is slightly more than minimal risk, the potential benefits to each patient outweigh this risk. As 58% of patients have persistent OSA postsurgery and the average trajectory of OSA severity is an increase over time, post-operative imaging and modeling can benefit the patient by identifying the changes to the airway made during surgery and which anatomy should be targeted in future treatments.
CONDITIONS
Official Title
Improving Outcomes in Pediatric Obstructive Sleep Apnea With Computational Fluid Dynamics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female
- Age 5 to 18 years for Aim 1 and xenon use
- Age 3 to 18 years for Aims 2 and 3
- Persistent moderate or severe obstructive sleep apnea after adenotonsillectomy (oAHI greater than 5 per hour of sleep)
- Clinical indication or suspicion of upper-airway obstruction (such as enlarged lingual tonsils, large tongue, or small jaw)
- Failed a trial of CPAP treatment
- Parents who choose surgery without trying CPAP
- Require surgery for obstructive sleep apnea based on surgeon's clinical assessment
You will not qualify if you...
- Children adequately treated with CPAP
- Children with braces or metal rods
- Children with contraindications to sedation
- Standard MRI exclusions as defined by the radiology department
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
P
Penny New, MS
CONTACT
C
Carrie Stevens
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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