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Obstructive Sleep ApneaPhase 4OSA-MRINCT04991389

Improving Outcomes in Pediatric Obstructive Sleep Apnea With Computational Fluid Dynamics

A Phase 4 study testing 129-Xe in people with Obstructive Sleep Apnea, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 18 years
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
129-Xe
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
15 Aug 2019to 1 Sep 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Alex Sierra, MS, 513 803 9132, alex.sierra@cchmc.org

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

This project aims 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, measured as a reduction in the obstructive apnea-hypopnea index (obstructive events per hour of sleep), is surprisingly low. Therefore, there is a clear need for a tool to improve the efficacy of these surgeries and predict which of the various surgical options 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.

Pediatric obstructive sleep apnea (OSA) is a sleep-related breathing disorder characterized by upper airway obstruction. This disorder affects 2.2 million children in the US alone.1 If untreated, OSA can result in behavioral, cognitive, metabolic, and cardiovascular morbidities.2,3 Although adenotonsillectomy (T\&A) is the first-line treatment, a large percentage of children have persistent OSA after T\&A.4-11 Continuous positive airway pressure (CPAP) is generally the second-line treatment;12 however, children have a compliance rate of only 50%.13 Children with persistent OSA who are noncompliant with CPAP often undergo surgery targeting soft tissue and/or bony structures surrounding the upper airway, with success rates ranging from 17% to 72%.14-17. The investigators preliminary data shows that 58% of patients who underwent soft tissue surgery post-T\&A had persistent moderate or severe OSA after the subsequent surgery. The goal of this study is therefore to provide a predictive model that determines which post-T\&A surgical procedure is most likely to be effective in each individual surgical candidate. This goal will be achieved through patient-specific computational fluid dynamics (CFD) models of airflow and upper airway collapse in these children. Novel CFD models of OSA that uniquely incorporate airway motion derived from 3 dimensional (3D) dynamic magnetic resonance imaging (MRI) obtained synchronously with airflow measurement were developed.18,19 Clinicians currently have no method of determining the contribution of neuromuscular control and air pressure forces in causing airway collapse or determining if the resistance to airflow in one portion of the upper airway induces collapse at another portion of the airway. Patient-specific CFD can provide this information and thereby become an invaluable tool in assisting clinicians in choosing the surgical procedure that is most likely to optimize outcomes.

The overall hypothesis is that the application of novel CFD models will produce a validated approach to accurately predict the surgical option with the most successful outcome. This hypothesis will be tested by (1) validating CFD for surgical planning, (2) identifying anatomic and aerodynamic factors (eg, changes in local resistance and flow-induced pressure forces due to post surgical changes in anatomy) that determine surgical outcomes, and (3) developing a virtual surgery platform to identify patient-specific surgical procedures that will lead to successful outcomes.

Being tested
129-Xe
Keywords
OSA, 129Xe, MRI, CFD simulations
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 129-XeDrug

    Inhaled contrast for MRI

Study groups in NCT04991389
Study groupRoleWhat they receive
Phase 1 - Contrast 129Xe MRI ages 5-18ExperimentalThe 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.
Receives: Drug: 129-Xe
Phase 2 - Contrast 129Xe MRI ages 3-18ExperimentalThe 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.
Receives: Drug: 129-Xe

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    To solve the equations governing flow (the Navier-Stokes Equations), the airway model will be divided into 3-5 million cells using Star-CCM+ (Siemens PLM Software, Plano, TX). The inlet flow boundary condition for CFD simulations will be the respiratory flow rate as measured by an MRI-compatible pneumotach,83 which records flow rates synchronously with MRI. The flow solver (also Star-CCM+) will compute the pressure and velocity fields down to the resolution of the cells. The influence of flow features smaller than the cells will be calculated using the large eddy simulation (LES) turbulence model.46,69,84 The duration of the breath will be divided into time-steps lasting 0.1 ms, and the flow solution calculated for each timestep. In between each time-step, the airway model will be moved according to the results of the image registration.18 The result will be temporal and spatial maps of the air flow velocity and pressure throughout the breath.

    Measured: 90 days

  2. Measure changes in geometric analysis of airway, airway resistance, and pressure forces with surgical outcome as measured by changes in oAHI (obstructive apnea-hypopnea index)

    Surgical interventions aimed at reducing the oAHI in patients with persistent OSA post-T\&A have variable success rates. Airway obstruction in each child can be characterized by geometric analysis of the airway, airway resistance, pressure forces, and the cause of airway collapse (either due to air pressure forces or neuromuscular control). Comparing the changes in these characteristics with the actual surgical outcome, measured by change in the oAHI, will reveal which characteristics determine surgical success.

    Measured: 90 days

Secondary outcomes (1)
  1. Ranking of predicted surgical treatment plans based on outcome changes in oAHI and actual surgical procedure

    Produce a surgical planning platform for patients with persistent OSA post-T\&A that predicts the surgery most likely to be successful. Predicted surgical plans will include the type of surgery most likely to be successful, and the location and volume of tissue to be resected. Subjects will be classified into 2 groups: those where the actual type of surgery performed on the subject is the same as the optimal type of surgery determined by patient-specific CFD modeling and those where a different surgery was performed (projected to be 25% and 75% of subjects, respectively based on current surgical outcomes. The outcome will be measured by comparing the surgical success rates (measured by reduction in the oAHI) between these groups.

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2021
  2. Study start15 Aug 2019
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04991389
Sponsor's protocol ID
OSA MRI_2019-0759
Acronym
OSA-MRI
Status last verified
Jan 2026
First submitted
9 Apr 2021
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 129-Xe in people with Obstructive Sleep Apnea, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Penny New, MS ((513) 636-9973, Penny.New@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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