Actively Recruiting

Phase 4
Age: 3Years - 18Years
All Genders
NCT04991389

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

Age: 3Years - 18Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

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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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