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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.

Must not have

Children who have a contraindication to sedative

Children adequately treated with CPAP

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I may have a blocked airway due to issues like a large tongue or small jaw.

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I have tried CPAP therapy without success.

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I am between 3 and 18 years old.

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I still have severe sleep apnea after surgery, with an oAHI > 5.

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I may have a blockage in my upper airway due to conditions like a large tongue or small jaw.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child cannot have sedatives due to health reasons.

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My child is successfully treated with CPAP.

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My child has braces or metal rods.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Operative Surgical Procedures

Awards & Highlights

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.

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.

0 / 8Eligibility criteria met