Prolonged Hypoxic Breathing in Healthy Volunteers: a Safety Study

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 12
• Participant gender: Both

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Ferrari, Michele, M.D., Massachusetts General Hospital, Harvard Medical School; Fisher, Daniel, R.R.T., Massachusetts General Hospital, Harvard Medical School; Harris, Stuart N., M.D., Massachusetts General Hospital, Harvard Medical School; Jain, Isha, B.A., Massachusetts General Hospital, Harvard Medical School; Karaa, Amel, M.D., Massachusetts General Hospital, Harvard Medical School; Mootha, Vamsi, M.D., Massachusetts General Hospital, Harvard Medical School; Patel, Sarvagna, B.A., Massachusetts General Hospital, Harvard Medical School; Rezoagli, Emanuele, M.D., Massachusetts General Hospital, Harvard Medical School; Zapol, Warren M., M.D., Massachusetts General Hospital, Harvard Medical School
• Last Updated: 2016-09-20

Criteria

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 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

• Currently enrolled in another research study

• Facial abnormalities that would preclude proper use of a face mask

Pregnancy Prevention/Testing: Women using oral, subdermal or injectable contraceptives, and those using other means of birth control may participate. A urine pregnancy test will be conducted as part of the screening process for study participation no more than 7 days before starting the study. The test result will be read by a female staff member who will keep the result confidential. If a woman declines to have a pregnancy test, she will not be able to participate.