NCT04991389 Improving Outcomes in Pediatric Obstructive Sleep Apnea With Computational Fluid Dynamics
| NCT ID | NCT04991389 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2019-08-15 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2019-08-15 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Alister Bates, PhD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT04991389 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 18 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04991389 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04991389 currently recruiting?
Yes, NCT04991389 is actively recruiting participants. Contact the research team at Penny.New@cchmc.org for enrollment information.
Where is the NCT04991389 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT04991389 clinical trial?
NCT04991389 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Alister Bates, PhD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 120 participants.