NCT04991389 · Children's Hospital Medical Center, Cincinnati
Improving Outcomes in Pediatric Obstructive Sleep Apnea With Computational Fluid Dynamics
(OSA-MRI)
What this study 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.
View original scientific description
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.
Interventions
DRUG
129-Xe
Inhaled contrast for MRI
Primary outcome measures
Predict the surgical option with the most successful outcome with patient-specific validation computational fluid dynamics (CFD) airflow simulations of respiratory upper airways of children with DS and OSA using inhaled Xenon gas phase-contrast MRI.
Time frame: 90 days
To solve the equations governing flow (the Navier-Stokes Equations), the airway model will be divided into 3-5 million cells using Star-CCM+ (Siemens PLM Software, Plano, TX). The inlet flow boundary condition for CFD simulations will be the respiratory flow rate as measured by an MRI-compatible pneumotach,83 which records flow rates synchronously with MRI. The flow solver (also Star-CCM+) will compute the pressure and velocity fields down to the resolution of the cells. The influence of flow features smaller than the cells will be calculated using the large eddy simulation (LES) turbulence model.46,69,84 The duration of the breath will be divided into time-steps lasting 0.1 ms, and the flow solution calculated for each timestep. In between each time-step, the airway model will be moved according to the results of the image registration.18 The result will be temporal and spatial maps of the air flow velocity and pressure throughout the breath.
Measure changes in geometric analysis of airway, airway resistance, and pressure forces with surgical outcome as measured by changes in oAHI (obstructive apnea-hypopnea index)
Time frame: 90 days
Surgical interventions aimed at reducing the oAHI in patients with persistent OSA post-T\&A have variable success rates. Airway obstruction in each child can be characterized by geometric analysis of the airway, airway resistance, pressure forces, and the cause of airway collapse (either due to air pressure forces or neuromuscular control). Comparing the changes in these characteristics with the actual surgical outcome, measured by change in the oAHI, will reveal which characteristics determine surgical success.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or Female
- Subjects between the ages of 5 to 18 only for Aim 1 and xenon use
- Subjects 3-18 years of age for Aims 2 and 3
- Subjects with persistent moderate or severe OSA after adenotonsillectomy. - -- Persistent moderate or severe OSA will be defined as an oAHI \> 5 per hour of sleep.
- Clinical indication or suspicion of upper-airway obstruction. Examples include but not limited to hypertrophy of the lingual tonsils, disproportionately large tongue, or micrognathia.
- Subjects who have failed a trial of CPAP.
- Subjects whose parents elect to pursue surgery without a trial of CPAP.
- Subjects who require a surgical procedure for OSA based on the clinical assessment of the surgeon (otolaryngologist or plastic surgeon).
Exclusion criteria
- Children adequately treated with CPAP.
- Children with braces/metal rods.
- Children who have a contraindication to sedative.
- Standard MRI exclusion criteria as set forth by the CCHMC Department of Radiology.
Where
- Cincinnati, Ohio
Collaborators
National Institutes of Health (NIH)
Related conditions & keywords
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Data: ClinicalTrials.gov · synced Jan 7, 2026 · Source of record for eligibility and locations