Prolonged Hypoxic Breathing in Healthy Volunteers: a Safety Study (NCT02860975) | Clinical Trial Compass
TerminatedNot Applicable
Prolonged Hypoxic Breathing in Healthy Volunteers: a Safety Study
Stopped: Data analysis completed after half volunteers were enrolled
United States5 participantsStarted 2017-01
Plain-language summary
The purpose of this study is to define the safety and the biochemical-physiological response of prolonged exposure to a normobaric low-oxygen environment in healthy volunteers.
Who can participate
Age range18 Years – 40 Years
SexALL
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Inclusion criteria
* Have a photo identification (ID)
* Male or female individuals age between 18 and 40 years old
* BMI between 19 and 24.9 kg/m2
* Having capacity to consent to the study Exclusion criteria
* Evidence of any physical, mental, and/or medical conditions that would make the proposed studies relatively more hazardous
* Prior high altitude pulmonary edema (HAPE) or high-altitude cerebral edema (HACE) diagnosis
* Born at altitudes greater than 2,100 m (\~7,000 ft)
* Systemic disease with or without any functional limitation; including
* controlled hypertension
* controlled diabetes without systemic effects
* Pregnancy determined by urine pregnancy test, detecting presence of human chorionic gonadotropin (hCG), or less than six weeks postpartum
* Women who are not willing to receive urine pregnancy tests
* Active smoking. Volunteers may be enrolled if they quit smoking for more than 1 year.
* Excess alcohol use: more than ½ L/day of wine consumption or equivalent
* Any current medication use except oral contraceptives.
* Living in areas that are more than 1,200 m (\~4,000 feet), or have traveled to areas that are more than 1,200 m for more than four days within the last 2 months
* Tobacco chewers
* Abnormal hemoglobin or hematocrit levels or presence of hemoglobin S
* Evidence of apnea or other sleeping disorders
* Evidence of asthma
* Lower respiratory infection within the last 30 days
* If applicable, unwilling to refrain from using energy drinks or other c…