A Study Evaluating Respiratory Causes Impacting Pilot Performance
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-000025
- Scottsdale/Phoenix, Arizona: 19-000025
Sponsor Protocol Number: 19-000025
About this study
The purpose of this study is to complete a series of three distinct tasks to address respiratory causes impacting pilot performance.
Task 1, entitled "Variable Oxygen Concentration Study," is to evaluate the three exposure variables through three study aims - differing on the oscillation frequency time windows or amplitude of the oxygen/nitrogen fluctuations.
The purpose of Task 2, entitled "The Cognitive Performance Cost of Increased Work of Breathing: Phase II," is to determine the impact of inspiratory and expiratory pressure-threshold loading on cognitive performance.
The purpose of Task 3, entitled "Causes of Decrements in Lung Physiology in High Performance Flight Operations," will be to understand the influence of various respiratory loads on development of decrements in lung physiology.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Between the ages of 18-50 years old.
- Are of moderate to high fitness level and participate in regular physical activity.
- Must have a body mass index (BMI) less than 31 kg/m^2.
- Must be able to provide clear informed written consent.
Exclusion Criteria:
- History of chronic respiratory, cardiovascular, metabolic disease or neural/cognitive disorders.
- Anemia (< 12 g/dl for males, < 11 g/dl for females).
- Migraines.
- Active smoker (smoke within the past 6 years), or have more than 5 pack-years of smoking history
- Females who are pregnant or trying to become pregnant.
Task 1 Specific:
- History of pneumothorax, functionally limiting barotraumas or any inability to equalize tympanic pressure (e.g., during diving, swimming or flying).
- Current dental abscesses or jaw pain consistent with severe dental caries.
- Prior allergies or serious side effects from vasoconstrictors such as Afrin™ (oxymetazoline hydrochloride) utilized for sinus decongestion.
- Hyperbaric exposure within the last 24 hours (for chamber visits).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Bruce Johnson, Ph.D. |
Closed for enrollment |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Bruce Johnson, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available