Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude

Mayo Clinic

Status and phase: Completed; Early Phase 1

Conditions: Cancer

Treatments: Other: Continuous Positive Airway Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT02852473

16-001685

Details and patient eligibility

About

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.

Full 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).

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Continuous Positive Airway Pressure

Experimental group

Description:

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

Treatment:

Other: Continuous Positive Airway Pressure