Induced Changes in Ventilatory Responsiveness and Altitude Exposure
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 Drug Administration (FDA) as a treatment or antidote for Tylenol overdoses. Other forms of ACCY are also sold over-the-counter as nutritional supplements. In this study, the FDA-approved form of ACCY will be used "off-label" (meaning in a way not approved by the FDA).
This study is being conducted by researchers from the United States Army Research Institute of Environmental Medicine (USARIEM). The study will take place in the Altitude Chamber located in the basement of USARIEM. A total of approximately 30 volunteers (men and women, military and civilians) will take part in the study. They can expect to be in the study for a minimum of a few hours each day for two weeks.
The investigators hypothesize that ACCY will improve ventilation and oxygenation while at altitude.
|Effects of High Altitude Hypoxia Inadequate or Impaired Breathing Pattern or Ventilation Abnormal Blood Oxygen Pressure||Drug: NAC Drug: Placebo||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Modulation of Oxygen Sensor Reactivity to Mimic Altitude Acclimatization|
- Arterial Oxygen Saturation [ Time Frame: Day 4 of treatment during acute altitude exposure ]Finger Pulse Oximetry to measure arterial oxygen saturation
|Study Start Date:||November 2010|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
NAC provided to determine if beneficial at altitude
Other Name: NAC Accy
Placebo Comparator: Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241513
|United States, Massachusetts|
|Natick, Massachusetts, United States, 01760|
|Principal Investigator:||Charles S Fulco, ScD||United States Army Research Institute of Environmental Medicine|