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 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT03525561
Eligibility Criteria:
Inclusion Criteria:
Volunteers must meet all of the following criteria to be included in the study:
* Male or female, age 18-45
* In good health as determined by Office of Medical Support and Oversight (OMSO) General Medical Clearance
* Passed his/her most recent Army Physical Fitness Test (APFT; military volunteers only) or exercise at least 2 times per week (civilian volunteers)
* Willing to not exercise, drink alcoholic beverages, or consume caffeinated products for 24 hours before each testing session.
* Willing not to consume carbonated beverages during the experimental phases of the study (this does not include the two week break between experimental phases)
* Willing to stay and sleep in an altitude chamber (the size of a dorm room) \~60 hours total (two \~30 hr exposures).
* Body mass index (BMI) ≤ 28.5
Exclusion Criteria:
* Females who are pregnant or planning to become pregnant during the study
* Taking dietary supplements, prescriptions, or over the counter medication, other than a contraceptive (unless approved by OMSO and PI)
* Born at altitudes greater than 2,100 m (\~7,000 feet; Examples include Santa Fe, New Mexico; Laramie, Wyoming; Etc.)
* Living in areas that are more than 1,200 m (\~4,000 feet), or have traveled to areas more than 1,200 m for five days or more within the last 2 months (Examples include Ft. Huachuca, Arizona; Lima, Peru; Feldberg, Germany; etc.)
* Physical problems/injuries associated with walking or running on a treadmill
* Allergy to skin adhesive
* Abnormal blood count (For example: hemoglobin (Hb) outside of the normal ranges (Normal \[Hb\] Males = 12.6-17.7 g/dL; Females = 11.1-15.9 g/dL) or hematocrit (Hct) outside of the normal ranges (Normal Hct Males = 37.5-51.0%; Females = 34.0-46.6%) levels, presence of abnormal blood chemicals (hemoglobin S or sickle cell traits)
* Prior HAPE (high altitude pulmonary edema) or HACE (high altitude cerebral edema) diagnosis
* Smokers or tobacco/nicotine users (unless have quit more than 4 months prior)
* Presence of asthma or respiratory tract infections (unless more than 1 month prior or approved by OMSO).
* Allergy to sulfa drugs (Acetazolamide)
* Evidence of apnea or other sleeping disorders
* History of neurologic (e.g. stroke, seizure), speech, facial muscle disorder or injuries preventing from producing normal range of hand and finger motion
* Experiencing colds, coughs, or sinus infections
* Food allergies/intolerances to gluten and/or dairy
* Low blood Na+/K+ values ( Na+: \< 135 mmol/L, K+: \<3.5 mmol/L)
* Kidney, liver or adrenal dysfunction
* Breastfeeding mothers
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03525561
Study Brief:
Protocol Section:
NCT03525561