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:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT05037032
Eligibility Criteria:
Inclusion Criteria:
1. Healthy males or females
2. Age 18 to 35 years of age
3. Body-mass index (BMI) ≤ 27
4. At least two weeks after full vaccination for Sars-CoV-2. Proof of vaccination will be determined by the investigators.
Exclusion Criteria:
1. Current smoker or significant past smoking history (≥ 10 pack-years)
2. History of COPD, interstitial lung disease or other pulmonary disease that in the opinion of the investigators would compromise the subject's safety at altitude
3. History of obstructive sleep apnea, or other history of sleep disordered breathing, or previous use of nighttime continuous positive airway pressure (CPAP)
4. Any history of chronic opioid use or prior abuse history
5. Any history of alcohol abuse
6. Use of any opioid substance (prescribed or otherwise) within 2-weeks of study enrollment
7. Any medications that might, in the opinion of the investigators, interfere with or alter respiratory control, (e.g. acetazolamide). Use of oral contraceptive medications would be allowed as long as the study subject is on the same agent/dose during both arms of the study.
8. Recent (within 3 weeks) exposure to altitudes ≥ 3,500 m at time of 1st altitude trip
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT05037032
Study Brief:
Protocol Section:
NCT05037032