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Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude

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ClinicalTrials.gov Identifier: NCT02852473
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Erik J. Tryggestad, Ph.D., Mayo Clinic

Brief Summary:

This study involves a breathing motion assessment in healthy subjects before and after continuous positive airway pressure (CPAP) administration using MRI images.

The hypothesis for this study is that CPAP administration will significantly reduce breathing motion. This may help cancer patients who are undergoing proton radiotherapy, so they possibly will not have to hold their breath during the procedure.


Condition or disease Intervention/treatment Phase
Cancer Other: Continuous Positive Airway Pressure Early Phase 1

Detailed Description:
Minimally invasive techniques for tumor motion reduction that involve free-breathing patients have significant relevance in the context of radiation therapy, in particular proton radiotherapy. Tumor motion reduction has favorable implications for reduction of radiation doses to adjacent healthy organs, radiation plan robustness (accuracy/quality) and for treatment efficiency (reduction of treatment times). Using non-ionizing MRI with volunteers, the investigators will determine the extent to which continuous positive airway pressure (CPAP) reduces breathing motion (diaphragmatic excursion). The researchers will also investigate the parameter space associated with breathing motion reduction versus the amount of pressure applied, as well as timing of initiation of CPAP in relation to the imaging time point (to address whether an initial transient breathing state exists).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude
Study Start Date : July 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Continuous Positive Airway Pressure
Continuous Positive Airway Pressure (CPAP) will be administered using FDA-approved equipment.
Other: Continuous Positive Airway Pressure
CPAP requires subjects to wear a plastic pressurized mask/apparatus, which is connected via a filter and hose to a pump capable of supplying variable pressure (typically on the range of 4-20 cm H2O). The investigators plan to use a full-face mask to prevent subjects from reducing pressure by opening their mouths. If this cannot be tolerated or properly fitted, or is not compatible with the CPAP ventilator, subjects would use a nasal mask only and be asked to keep their mouths closed.




Primary Outcome Measures :
  1. Change in Breathing Motion Characteristics at High CPAP Setting [ Time Frame: Data acquisition for this portion of the study will require approximately 30 minutes. ]
    Breathing motion at baseline and at initial (higher but tolerable) CPAP settings will be characterized using fast multi-slice, multi-phase 2D gradient-echo or spin-echo MRI sequences in the sagittal or coronal imaging planes over a large field of view covering the thoracic and upper-abdominal region. Specifically "4D-MRI" (or time-resolved MRI) will be generated from retrospective sorting of multi-slice 2D MRI. For these analyses, anatomic reference points (e.g., bright vessels) in multiple organ systems will be identified on the images, contoured or segmented; subsequently 3D motion patterns will be extracted for all anatomical references/features. Numerical simulations will be performed to determine hypothetical radiation target volume changes (cm^3) at these anatomic locations assuming spherical tumors with a given set of tumor diameters (cm).


Secondary Outcome Measures :
  1. Change in Breathing Motion Characteristics at Lower CPAP Setting [ Time Frame: Approximately 45 minutes into visit. ]
    Time permitting, the CPAP setting will be reduced to approximately half of the nominal/tolerable/high CPAP setting. Using the same MRI sequences and retrospective sorting technique, 4D-MRI will be generated for this lower CPAP setting. Analogous motion characterization analyses (to outcome measure 1) will be carried out for the lower CPAP setting (relative to baseline 4D-MRI).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult female and males
  2. Subject meets routine MRI safety criteria

Exclusion Criteria:

  1. Age <18
  2. Known history of chronic obstructive pulmonary disease (COPD), asthma, or other chronic pulmonary illness
  3. Pregnancy
  4. Any safety risk identified via MRI safety screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852473


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Erik J Tryggestad, PhD Mayo Clinic
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Responsible Party: Erik J. Tryggestad, Ph.D., Associate Professor of Medical Physics, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02852473    
Other Study ID Numbers: 16-001685
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Erik J. Tryggestad, Ph.D., Mayo Clinic:
Continuous Positive Airway Pressure
Radiotherapy
Proton Therapy
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes