Improving surgical outcomes for children with obstructive sleep apnea using advanced imaging techniques
Improving Outcomes in Pediatric Obstructive Sleep Apnea With Computational Fluid Dynamics
This study is testing a new tool that uses advanced imaging to help doctors predict how well surgery will work for children with sleep apnea who haven't improved with other treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT04991389 on ClinicalTrials.gov |
What this trial studies
This project aims to develop a validated computational tool that predicts surgical outcomes for pediatric patients suffering from obstructive sleep apnea (OSA). The study focuses on children aged 3 to 18 who have persistent moderate or severe OSA after adenotonsillectomy and have either failed CPAP treatment or are opting for surgery. By utilizing computational fluid dynamics (CFD) simulations alongside real-time magnetic resonance imaging (MRI), the research seeks to compare various surgical options virtually, enhancing the decision-making process for individualized treatment. The goal is to improve the efficacy of surgical interventions aimed at alleviating airway obstruction in these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 18 with persistent moderate or severe OSA after adenotonsillectomy who have failed CPAP treatment.
Not a fit: Patients who are adequately treated with CPAP or have contraindications to sedatives will not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could significantly improve surgical outcomes for children with obstructive sleep apnea by providing tailored treatment options.
How similar studies have performed: While CFD simulations have been used in other contexts, this specific application for predicting surgical outcomes in pediatric OSA is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Alister Bates, PhD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Penny New, MS
- Email: Penny.New@cchmc.org
- Phone: (513) 636-9973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.