Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT05801120
Eligibility Criteria:
Inclusion Criteria:
* Males \& females between 18 and 39 years old.
* Predicted (Phase 1) VO2max ≥ 30 ml/kg/min (female) or 35 ml/kg/min (male).
* BMI ≤ 30.0 unless VO2max and baseline exercise profile is deemed appropriate for the study by the PI.
Exclusion Criteria:
* Prolonged QTc on initial ECG
* Currently pregnant or attempting to become pregnant.
* Have a medical history of:
1. Smoking history deemed significant by PI
2. Known significant electrolyte disorders
3. Coronary artery disease
4. Cardiac arrhythmia deemed significant by PI
5. Lung disease
6. Hypertension
7. Seizures
8. Exercise intolerance or inability to meet inclusion requirements
9. Psychiatric disorder deemed significant by PI
10. Previous pneumothorax or pneumomediastinum
11. Hypo- or hyperglycemia
12. Diabetes
13. Inability to equalize middle ear spaces during hyperbaric compression
14. Claustrophobia
* Regularly take any medications which may alter heart rate, blood pressure, neurotransmitter function, alter seizure threshold, mood or affect per PI discretion.
* Any other condition limiting ability to perform exercise testing or dive profile as determined by the investigators.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT05801120
Study Brief:
Protocol Section:
NCT05801120