Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude

NCT02852473 | Completed Early Phase 1

• 1 other identifier: 16-001685
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Continuous Positive Airway Pressure; Radiotherapy; Proton Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Breathing Motion Characteristics at High CPAP Setting

  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).

  Data acquisition for this portion of the study will require approximately 30 minutes.

Secondary Outcomes (1)

• Change in Breathing Motion Characteristics at Lower CPAP Setting

  Approximately 45 minutes into visit.

Study Arms (1)

Continuous Positive Airway Pressure

EXPERIMENTAL

Continuous Positive Airway Pressure (CPAP) will be administered using FDA-approved equipment.

Other: Continuous Positive Airway Pressure

Interventions

Continuous Positive Airway Pressure OTHER

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.

Continuous Positive Airway Pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult female and males
• Subject meets routine MRI safety criteria

You may not qualify if:

• Age \<18
• Known history of chronic obstructive pulmonary disease (COPD), asthma, or other chronic pulmonary illness
• Pregnancy
• Any safety risk identified via MRI safety screening

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Erik J Tryggestad, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medical Physics

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: August 2, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

US (1)