Induced Changes in Ventilatory Responsiveness and Altitude Exposure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01241513|
Recruitment Status : Terminated (Results of preliminary analyses showed no reason to continue the study)
First Posted : November 16, 2010
Results First Posted : May 18, 2016
Last Update Posted : May 18, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Effects of High Altitude Hypoxia Inadequate or Impaired Breathing Pattern or Ventilation Abnormal Blood Oxygen Pressure||Drug: NAC Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Modulation of Oxygen Sensor Reactivity to Mimic Altitude Acclimatization|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
NAC provided to determine if beneficial at altitude
Other Name: NAC Accy
Placebo Comparator: Placebo
- Arterial Oxygen Saturation [ Time Frame: Day 4 of treatment during acute altitude exposure ]Finger Pulse Oximetry to measure arterial oxygen saturation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241513
|United States, Massachusetts|
|Natick, Massachusetts, United States, 01760|
|Principal Investigator:||Charles S Fulco, ScD||United States Army Research Institute of Environmental Medicine|