← Back to Search

Gas

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

N/A

Waitlist Available

Led By Lorenzo Berra, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female individuals age between 18 and 40 years old

Having capacity to consent to the study

Must not have

Evidence of apnea or other sleeping disorders

Any current medication use except oral contraceptives

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at how safe and effective it is to expose healthy volunteers to low-oxygen environments.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include symptoms related to low oxygen levels such as dizziness, shortness of breath, headache, and increased heart rate. The full extent will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 40 years old.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with a sleeping disorder like apnea.

Select...

I am taking medication, but not oral contraceptives.

Select...

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

Select...

My high blood pressure is under control.

Select...

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

Select...

I have asthma.

Select...

I am not willing to take urine pregnancy tests.

Select...

My diabetes is under control without affecting my whole body.

Select...

I have abnormal blood levels or sickle cell trait.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Peripheral oxygen saturation

Secondary study objectives

Acid-base status

Anaerobiotic glycolytic pathway

Energy metabolism

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 11Eligibility criteria met