Status:
TERMINATED
Induced Changes in Ventilatory Responsiveness and Altitude Exposure
Lead Sponsor:
United States Army Research Institute of Environmental Medicine
Conditions:
Effects of High Altitude
Hypoxia
Eligibility:
All Genders
18-39 years
Phase:
PHASE4
Brief Summary
The main purpose of this study is to determine if a drug (acetyl-cysteine or ACCY) can increase the amount of oxygen in your body at a high altitude of 11,500 feet. ACCY is approved by the Food and Dr...
Detailed Description
This study will determine if modulating reduction/oxidation (redox) status through a temporary increase in the blood ratio of reduced-to-oxidized glutathione (i.e., GSH/GSSG) will increase carotid bod...
Eligibility Criteria
Inclusion
- \-
Exclusion
- Volunteers with the following criteria will be EXCLUDED from participation:
- Less than 18 years of age Greater than 39 years of age Born at altitudes greater than 2134 m (7000 ft) Living in areas that are more than 1220 m (4,000 feet), or have traveled to areas that are more than 1220 m for more than a few days within the last 2 months.
- Abnormal \[Hb\]/Hct levels or presence of hemoglobin S Known allergies to sulfonamide derivatives Smokers who smoke more than 5 cigarettes per day Tobacco chewers If military, unable to pass the 2-mi run portion of the Army Physical Fitness Test, or equivalent If civilian, not currently running or exercising for at least 20 min/day, 3X/week in "aerobic" activities (e.g., running, biking. swimming, basketball, etc) If they do not want to walk or run multiple times for 1 to 3 hours on a treadmill Unable to meet the U.S. Army height/weight standards Not willing to sleep in bunk beds in a small room (8 feet by 8 feet) with 1 to 3 other volunteers (male and/or female) for 3 nights. If they are claustrophobic Women who are pregnant or planning to conceive during the study period Women who are not willing to take urine pregnancy tests Not willing to drink an eight ounce solution of diet soda that may contain ACCY up to three times per day and then not willing to suck on a peppermint mint right after drinking the solution.
- Taking medications that interfere with oxygen delivery and transport (Includes sedatives, sleeping aids, tranquilizers and any medication that depresses ventilation, diuretics, alpha and beta blockers) Evidence of any physical, mental, and/or medical conditions that would make the proposed studies relatively more hazardous. Evidence of prior HAPE or HACE diagnosis Evidence of apnea or other sleeping disorders Evidence of asthma If applicable, unwilling to stop taking all supplements for the two weeks of participation If applicable, all medications (prescription or over-the-counter) must be approved by the PI, and/or the OMSO.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01241513
Start Date
November 1 2010
End Date
February 28 2013
Last Update
April 30 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
USARIEM
Natick, Massachusetts, United States, 01760