Hypoxic Breathing Safety Study for Healthy Volunteers (MGH-nitrogen Trial)

Palo Alto (17 mi)

Overseen byLorenzo Berra, MD

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Healthy adults aged 18-40 with a BMI of 19-24.9, able to consent and provide photo ID can join this trial. It's not for those born or living at high altitudes, heavy drinkers, pregnant women, smokers, or anyone with certain medical conditions like uncontrolled hypertension or diabetes.

Inclusion Criteria

I am between 18 and 40 years old.

I am able to understand and agree to participate in the study.

Exclusion Criteria

I have been diagnosed with a sleeping disorder like apnea.

I am taking medication, but not oral contraceptives.

I have had high-altitude lung or brain swelling before.

My high blood pressure is under control.

I am not willing to have blood drawn from my arm on test days.

I have asthma.

I am not willing to take urine pregnancy tests.

My diabetes is under control without affecting my whole body.

I have abnormal blood levels or sickle cell trait.

Treatment Details

The study tests the safety of breathing low-oxygen air (inhaled nitrogen) in a controlled environment among healthy volunteers to understand how their bodies respond over time.

1Treatment groups

Experimental Treatment

Group I: Inhaled NitrogenExperimental Treatment1 Intervention

A humidified mixture of gas will be delivered by mask, nasal cannulae, and small room-sized tent. Inspiratory oxygen fraction (FiO2) will be gradually decreased to 11% over a period or five days to obtain a peripheral capillary O2 saturation (SpO2) between 80%-85% (corresponding to 40-55 mmHg of arterial partial oxygen pressure (PaO2)). Healthy volunteers will be monitored and blood and urine will be obtained at 24h and 48 hours after returning to normoxia.