Clinical trial · Interventional
Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude
NCT02852473CI-TRIAL-00024269completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Continuous Positive Airway Pressure | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Continuous Positive Airway Pressure
- description
- Continuous Positive Airway Pressure (CPAP) will be administered using FDA-approved equipment.
- interventionNames
- Other: Continuous Positive Airway Pressure
Primary outcomes (1)
- measure
- Change in Breathing Motion Characteristics at High CPAP Setting
- timeFrame
- Data acquisition for this portion of the study will require approximately 30 minutes.
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.