Improving Outcomes in Pediatric Obstructive Sleep Apnea With Computational Fluid Dynamics

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT04991389
Phase
PHASE4
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • 129-Xe — DRUG
    Inhaled contrast for MRI

Study Details

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.

Key Dates

Start date
Aug 15, 2019
Status verified
Jan 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Phase 1 - Contrast 129Xe MRI ages 5-18
    The research team will collect data characterizing upper airway anatomy, motion, and airflow. In patients, these data may be recorded before and after surgery. The data may include some or all of the following: (1) Static and dynamic proton MRI of the airway. (2) Respiratory airflow measurements. (3) Phase contrast MRI of inhaled gas. (4) Data from clinical PSGs. (5) Measurements may be repeated at different levels of CPAP.
  • Experimental: Phase 2 - Contrast 129Xe MRI ages 3-18
    The research team plans to collect data characterizing upper airway anatomy, motion, and airflow. In patients, these data may be recorded before and after surgery. The data may include some or all of the following: (1) Static and dynamic proton MRI of the airway. (2) Respiratory airflow measurements. (3) Data from clinical PSGs. (5) Measurements may be repeated at different levels of CPAP.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Alex Sierra, MS
[email protected]
513 803 9132

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