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CFD Simulations for Pediatric Sleep Apnea (OSA-MRI Trial)
Phase 4
Recruiting
Led By Alister Bates, PhD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
OSA-MRI Trial Summary
This trial is testing a new tool to predict surgical outcomes for pediatric patients with obstructive sleep apnea (OSA). The goal is to improve the success rates of surgeries by using computational fluid dynamics (CFD) simulations of respiratory airflow in the upper airways.
Who is the study for?
This trial is for children aged 5-18 with obstructive sleep apnea (OSA) who haven't improved after tonsil and adenoid removal, or those who can't tolerate CPAP therapy. It's also open to kids needing surgery for OSA as per a surgeon's assessment. Kids with braces/metal rods, well-managed on CPAP, or unable to undergo MRI are excluded.Check my eligibility
What is being tested?
The study aims to develop a computational tool using Computational Fluid Dynamics (CFD) simulations based on real-time MRI data. This tool will predict which surgical options might best improve pediatric OSA by modeling airflow in the upper airways more accurately than previous methods.See study design
What are the potential side effects?
There may be risks associated with sedation required for post-operative imaging and potential discomfort from the MRI procedure itself. However, no direct side effects from the intervention being tested (the CFD simulation tool) are expected.
OSA-MRI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I may have a blocked airway due to issues like a large tongue or small jaw.
Select...
I have tried CPAP therapy without success.
Select...
I am between 3 and 18 years old.
Select...
I still have severe sleep apnea after surgery, with an oAHI > 5.
Select...
I may have a blockage in my upper airway due to conditions like a large tongue or small jaw.
OSA-MRI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Activation Analysis
Predict the surgical option with the most successful outcome with patient-specific validation computational fluid dynamics (CFD) airflow simulations of respiratory upper airways of children with DS and OSA using inhaled Xenon gas phase-contrast MRI.
Secondary outcome measures
Operative Surgical Procedures
OSA-MRI Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2 - Contrast 129Xe MRI ages 3-18Experimental Treatment1 Intervention
The research team plans to collect data characterizing upper airway anatomy, motion, and airflow. In patients, these data may be recorded before and after surgery. The data may include some or all of the following: (1) Static and dynamic proton MRI of the airway. (2) Respiratory airflow measurements. (3) Data from clinical PSGs. (5) Measurements may be repeated at different levels of CPAP.
Group II: Phase 1 - Contrast 129Xe MRI ages 5-18Experimental Treatment1 Intervention
The research team will collect data characterizing upper airway anatomy, motion, and airflow. In patients, these data may be recorded before and after surgery. The data may include some or all of the following: (1) Static and dynamic proton MRI of the airway. (2) Respiratory airflow measurements. (3) Phase contrast MRI of inhaled gas. (4) Data from clinical PSGs. (5) Measurements may be repeated at different levels of CPAP.
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,471 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
7,492,199 Total Patients Enrolled
Alister Bates, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I may have a blocked airway due to issues like a large tongue or small jaw.My child cannot have sedatives due to health reasons.I am between 5 and 18 years old.My parents chose surgery for me without trying CPAP first.I am either male or female.You have tried using CPAP machine before, but it did not work for you.I have tried CPAP therapy without success.I am between 3 and 18 years old.My child is successfully treated with CPAP.I still have severe sleep apnea after surgery, with an oAHI > 5.My child has braces or metal rods.I need surgery for sleep apnea as advised by my surgeon.I may have a blockage in my upper airway due to conditions like a large tongue or small jaw.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 - Contrast 129Xe MRI ages 5-18
- Group 2: Phase 2 - Contrast 129Xe MRI ages 3-18
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is this clinical trial being populated with participants?
"Affirmative. As evidenced on the clinicaltrials.gov website, 120 patients are being recruited at this time for a trial that was initially posted in August of 2019 and modified as recently as July 2021."
Answered by AI
What type of individuals are eligible to participate in this scientific research?
"This medical trial is recruiting 120 minors with apnea, ranging in age from 3 to 18. In order for a child to be enrolled, they must have persistent moderate or severe OSA after adenotonsillectomy; an oAHI > 5 per hour of sleep.; clinical indication or suspicion of upper-airway obstruction such as hypertrophy of the lingual tonsils or micrognathia; and parents who elect surgery without CPAP intervention. Both males and females are accepted for this study's aims 2 & 3."
Answered by AI
Does the protocol for this experiment include participants who have attained majority?
"This clinical trial is looking to enrol patients that are between 3 and 18 years old."
Answered by AI
Is participation in this research study still available for those who qualify?
"Per clinicaltrials.gov, this research endeavor is still looking for participants. It was originally advertised on August 15th 2019 with the most recent amendment happening almost two years later on July 27th 2021."
Answered by AI
Has the FDA given its stamp of approval for 129-Xe?
"There is a solid body of evidence confirming 129-Xe's safety, making it eligible for a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
California
Georgia
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
What site did they apply to?
Cincinnati Children's Hospital Medical Center
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