Prolonged Hypoxic Breathing in Healthy Volunteers: a Safety Study

Stopped early · Not applicable

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT02860975

Run by

Massachusetts General Hospital

People needed

5

Starts

2017-01-01

Expected to finish

2019-04-05

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 caffeinated beverages for 7 days prior to and during the study
• If applicable, unwilling to refrain from use of all over-the-counter oral medications, herbal remedies, and nutritional supplements for 7 days prior to and during the study
• Not willing to have blood drawn from an arm vein each test day of the study
• Claustrophobia (inability to wear a facemask) or other active psychiatric conditions or not willingness to cooperate with the investigators and the other medical team

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.