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NCT04991389 · ClinicalTrials.gov registry record · Phase 4
Improving Outcomes in Pediatric Obstructive Sleep Apnea With Computational Fluid Dynamics
A Phase 4 study of Obstructive Sleep Apnea, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT04991389 is a Phase 4 study of Obstructive Sleep Apnea that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 120 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04991389, a Phase 4 study of Obstructive Sleep Apnea, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study 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 slightl
Conditions Studied
Interventions
- DRUG 129-Xe
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-08-15 |
| Est. Completion | 2027-09-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04991389
The ClinicalTrials.gov registry entry for NCT04991389 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (46% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which 129-Xe is the first listed.
NCT04991389 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT04991389 about?
NCT04991389 is a clinical study titled "Improving Outcomes in Pediatric Obstructive Sleep Apnea With Computational Fluid Dynamics". 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, cont...
What is the current status of trial NCT04991389?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2019-08-15. Estimated completion is 2027-09-01.
What conditions does trial NCT04991389 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT04991389?
The interventions under investigation include: 129-Xe (DRUG).
Who is sponsoring clinical trial NCT04991389?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04991389 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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