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Improving Outcomes in Pediatric Obstructive Sleep Apnea With Computational Fluid Dynamics

RecruitingPhase 4Ages 3 Years - 18 YearsAllChildren's Hospital Medical Center, Cincinnati
NCT04991389 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • 129-Xe
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Where

1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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